Home Ingredients Bifidobacterium breve CECT7263

Bifidobacterium breve CECT7263

Bifidobacterium breve
Evidence Level
Limited
2 Clinical Trials
5 Documented Benefits
2/5 Evidence Score

Bifidobacterium breve CECT7263 is a probiotic strain isolated from human milk and developed by Biosearch Life of Granada, Spain, which Kerry Group bought in 2021; recent papers also call it BfM26. Two trials have tested the strain on its own, both in babies and both run with company-employed authors. In an open-label trial in 150 babies with colic, crying time fell in every group, and the percentage drop was larger with 200 million CFU a day of the strain than with simethicone, an anti-gas medicine, but there was no placebo group. In a double-blind trial in 236 healthy formula-fed babies, formula with the strain gave the same weight gain as standard formula, the main safety outcome, and fewer babies had long crying spells, a secondary result. No adult trials of the strain alone were found, and its results do not carry over to other B. breve strains.

Studied Dose Babies: 200 million CFU a day for 28 days (crying trial; the registry lists 100 million), or about 1 billion CFU a day to 6 months and 700 to 800 million CFU a day from 6 to 12 months in formula. No adult dose has been studied for the strain alone.
Active Compound Live Bifidobacterium breve strain CECT7263, isolated from human milk. Biosearch S.A. (Biosearch Life) of Granada, Spain held a patent application including the strain; Kerry completed its purchase of Biosearch Life in July 2021, and a 2025 paper by Kerry-employed authors calls the strain BfM26. In trials it was given as a powder from a capsule opened into milk or water, or added to infant formula at 10 million CFU per gram.

Benefits

Daily crying time in babies (open-label trial)

In an open-label randomized trial in 150 babies with colic, crying time fell in every group, including the group given simethicone, an anti-gas medicine. The drop was larger with 200 million CFU a day of B. breve CECT7263 from the first week. There was no placebo group and parents knew which product they gave, so the result cannot show how the strain compares with no treatment, and parent-recorded crying may be biased.

Supported by Trial 1

Long crying spells in healthy formula-fed babies

In a double-blind trial, babies fed formula with the strain from 1 to 12 months had lower odds of long crying spells than babies on standard formula; at 6 weeks, 12% versus 29% cried more than 3 hours a day. This was a secondary measure in a growth trial run with the maker, and sleep hours did not differ.

Supported by Trial 2

Night sleep and parent mood ratings during the crying trial

In the open-label crying trial, parents of babies given the strain reported better night sleep and a more positive mood at the end of 4 weeks. These were parent-reported secondary measures without a placebo group, and the 11-month formula trial found no difference in sleep hours versus standard formula.

Supported by Trial 1, Trial 2

Infections and fever in formula-fed babies

Over 11 months on formula with the strain, rates of diarrhea, upper and lower respiratory infections, ear infections and fever did not differ from standard formula. A lower rate of upper respiratory infections appeared only in the small subgroup of babies whose mothers smoked, a subgroup finding.

Supported by Trial 2

Blood pressure and gut acetate in rats (animal research)

In two rat studies from one Spanish laboratory, several weeks of the strain prevented a rise in blood pressure, raised short-chain fatty acid producing gut bacteria and improved blood vessel relaxation. These results come from animals bred or treated to develop high blood pressure and have not been tested in people.

Supported by Trial 1

Mechanism of action

1

A strain from human milk with little change in gut bifidobacteria

CECT7263 was isolated from human milk. In formula-fed babies given about 1 billion CFU a day, total gut Bifidobacterium counts did not differ from standard formula, which the authors attribute to the already high natural levels, while Clostridium counts were higher and brown stools more common. These are gut bacteria measures, not health outcomes.

2

Short-chain fatty acids and gut barrier markers in rats

In rat studies, the strain raised acetate and butyrate producing gut bacteria, lowered blood endotoxin and restored a balance of immune T cells, and acetate given alone mimicked its effects on blood pressure. This proposed route rests on animal work only.

3

Effects are strain specific

Results for CECT7263 do not carry over to other B. breve strains, and results for products pairing it with L. fermentum CECT5716 apply to the pair. In the crying trial, the pair at a lower dose of each strain began to cut crying a week later than CECT7263 alone.

Clinical trials

1
CECT7263 200 Million CFU vs Simethicone for 28 Days: Infant Crying Time (No Placebo Group)
PubMed

Multicenter open-label randomized trial comparing B. breve CECT7263 (200 million CFU a day), B. breve plus L. fermentum CECT5716 (100 million CFU a day of each) and simethicone (80 mg a day) for 28 days, with no placebo arm; main outcomes were daily crying minutes and their percentage drop, analyzed by intention to treat. Registered NCT03467334 about 8 months after the start, with no results posted; the registry lists masked investigators and assessors and gives the CECT7263 dose as 100 million CFU. Seven of the 15 named authors (Maldonado-Lobón JA, Blanco-Rojo R, Sañudo A, Rodríguez C, Bañuelos O, Fonollá J, Olivares M) were from Biosearch Life, a company in Granada (Maldonado-Lobón et al. 2021, Benef Microbes)

150 infants diagnosed with colic by Rome III criteria.

Crying time fell in all three groups. In the B. breve group it fell from the first week, and the percentage drop was larger than in the simethicone group each week (68.5% vs 59.5% at 4 weeks), with better night sleep reported. With no placebo group and parents aware of the product, the trial cannot show how much of the drop is due to the strain rather than natural improvement over time or parents knowing which product they gave.

2
CECT7263 in Infant Formula From 1 to 12 Months: Growth and Tolerance RCT
PubMed

Randomized double-blind controlled trial with three groups: standard formula, or the same formula with L. fermentum CECT5716 Lc40 or with B. breve CECT7263 at 10 million CFU per gram, from 1 to 12 months of age; main outcome was weight gain as a safety marker (1 to 4 months in the paper's methods; the registry lists 12 months). Funded by Biosearch Life with an Andalusian grant co-financed by the European Regional Development Fund; three authors (Maldonado-Lobón JA, Valero AD, Olivares M) worked for Biosearch Life, owner of the strain patent; retrospectively registered NCT03204630 (Maldonado et al. 2019, BMC Pediatr)

236 healthy formula-fed babies enrolled at 1 month of age in Spain; 189 completed (63 in the CECT7263 group).

Weight gain did not differ (5.58 kg on CECT7263 vs 5.77 kg on control from 1 to 12 months, p = 0.527; 1 to 4 months also similar), and no adverse effects were related to any formula. Odds of long crying spells were lower than on control (OR 0.569, p = 0.001; more than 3 hours a day at 6 weeks in 12% vs 29%). Diarrhea, respiratory infections, fever, sleep and gut Bifidobacterium counts did not differ.

Side effects and drug interactions

Common Potential side effects

In an 11-month double-blind trial in healthy formula-fed babies, formula intake, tolerance symptoms and growth did not differ from standard formula, and the authors reported no adverse effects related to the formula. In the 28-day crying trial, the authors describe all products as safe and well tolerated.
Laboratory work shows the strain carries an uncommon gene that makes it resistant to the antibiotics erythromycin and clindamycin; transfer to other bacteria was not detected in lab tests.
Preterm babies received CECT7263, combined with L. fermentum CECT5716, only in neonatal units. NCCIH notes that severe or fatal infections have been reported in premature infants given probiotics and that the risk of harm is greater in people with severe illness or weakened immunity. Ask a pediatrician before giving any probiotic to a baby.

Important Drug interactions

No drug interaction studies of CECT7263 were found; the points below are general precautions for live probiotics.
Antibiotics can kill live probiotic bacteria; ask a pharmacist how to space a probiotic around antibiotic doses.
Immunosuppressive drugs or chemotherapy: ask a doctor before using any live probiotic.

Explore Other Ingredients

Sleep Health
Melatonin
Melatonin is a hormone made by the pineal gland that signals biological darkness and helps…
Sleep Health
Valerian Root
Valerian root (Valeriana officinalis) is a traditional herb taken for relaxation and occas…
Metabolic Health
Magnesium
Magnesium is an essential mineral and a cofactor in more than 300 enzyme systems, includin…

Frequently asked questions about Bifidobacterium breve CECT7263

What is Bifidobacterium breve CECT7263?

It is a probiotic strain of Bifidobacterium breve isolated from human milk and developed by Biosearch Life in Granada, Spain. Kerry Group bought Biosearch Life in 2021, and recent papers also call the strain BfM26. It has been tested in babies on its own and together with L. fermentum CECT5716.

Does CECT7263 help with infant crying?

In an open-label trial in 150 babies with colic, crying time fell in every group and fell more with the strain than with simethicone, but there was no placebo group. In a formula trial, fewer babies on the strain had long crying spells, a secondary result. Both trials were run with the maker. Talk to a pediatrician about a crying baby.

How much CECT7263 was used in studies?

The crying trial used 200 million CFU a day for 28 days. The formula trial added 10 million CFU per gram of formula, about 1 billion CFU a day in the first 6 months. No adult dose has been tested for the strain alone. Follow the product label.

Is CECT7263 safe for babies?

Healthy babies fed formula with the strain for 11 months grew like babies on standard formula, with no formula-related adverse effects reported. Preterm babies received it with another strain only in hospital. Live probiotics carry more risk for premature, very sick or immune-compromised babies, so ask a pediatrician first.

What is Bifidobacterium breve CECT7263 used for?

NutraSmarts does not list Bifidobacterium breve CECT7263 under a health category. What the research covers: In an open-label randomized trial in 150 babies with colic, crying time fell in every group, including the group given simethicone, an anti-gas medicine. The drop was larger with 200 million CFU a day of B.

Does Bifidobacterium breve CECT7263 interact with any medications?

Possible interactions include: No drug interaction studies of CECT7263 were found; the points below are general precautions for live probiotics. Antibiotics can kill live probiotic bacteria; ask a pharmacist how to space a probiotic around antibiotic doses. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Bifidobacterium breve CECT7263?

NutraSmarts rates the evidence for Bifidobacterium breve CECT7263 as Limited (2 out of 5). It is backed by 2 study summaries and 11 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(11 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Maldonado-Lobón JA, Blanco-Rojo R, Maldonado J, Ali MA, Almazán MV, Suanes-Cabello A, Callejón E, Jaldo R, Benavídes MR, Negrillo AM, Sañudo A, Rodríguez C, Bañuelos O, Fonollá J, Olivares M, PROBI-COLIC group. Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial. Benef Microbes. 2021;12(1):55-67. doi: 10.3920/BM2020.0105.PubMedUsed to support: Open-label randomized trial in 150 infants with colic (Rome III criteria) given simethicone (80 mg a day), B. breve CECT7263 (200 million CFU a day) or CECT7263 plus L. fermentum CECT5716 (100 million CFU a day of each) for 28 days, with no placebo group. Crying time fell in all groups; with CECT7263 alone it fell from week 1 and the percentage drop was larger than with simethicone each week (68.5% vs 59.5% at 4 weeks), with better night sleep and more positive parent-reported mood. The authors describe all products as well tolerated. Seven of the 15 named authors were from Biosearch Life, the strain's owner.
  2. Maldonado J, Gil-Campos M, Maldonado-Lobón JA, Benavides MR, Flores-Rojas K, Jaldo R, Jiménez Del Barco I, Bolívar V, Valero AD, Prados E, Peñalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019;19(1):361. doi: 10.1186/s12887-019-1753-7.PubMedUsed to support: Randomized double-blind trial in 236 healthy formula-fed babies (189 completed, 63 in the CECT7263 group) given standard formula or the same formula with L. fermentum CECT5716 Lc40 or B. breve CECT7263 (10 million CFU per gram, about 1 billion CFU a day to 6 months) from 1 to 12 months. Weight gain, the main safety outcome, did not differ (5.58 kg with CECT7263 vs 5.77 kg control, p = 0.527). Babies on CECT7263 formula had lower odds of long crying spells (OR 0.569, p = 0.001); diarrhea, respiratory infections, fever and sleep did not differ from control. Funded by Biosearch Life with an Andalusian grant co-financed by the European Regional Development Fund; three authors worked for Biosearch Life, which held the strain patent; retrospectively registered (NCT03204630).
  3. Hurtado Suazo JA, Alonso Ojembarrena A, Sánchez Tamayo T, Martín Alvarez E, Saez ME, Martínez Pardo L, Díez Delgado Rubio J, Granero Asencio M, Serrano López L, Maldonado-Lobón JA, Mora Navarro D, de Benito Guerra MT, Torres Begara E, Ruiz Moreno JA, Macías Díaz C, Lloreda García JM, Peña Caballero M, Olivares M, Blanco-Rojo R. L.Fermentum CECT5716 and B.Breve CECT7263 on premature infants morbidities: a randomized clinical trial. Pediatr Res. 2026;100(1):309-316. doi: 10.1038/s41390-025-04633-6.PubMedUsed to support: Other product (CECT7263, called BfM26, combined with L. fermentum CECT5716). Randomized double-blind trial in 583 very low birth weight preterm babies in Spanish neonatal units comparing a high dose (1 billion CFU a day of each strain) with a low dose (1 million CFU a day of each), with no placebo group (NCT06501404, registered in 2024, about nine years after the January 2015 start). The serious bowel complication and death rates did not differ between doses; the combination was well tolerated with no adverse effects attributed to it. Kerry Group supplied the product; four authors are Kerry employees and three are inventors on a pending patent based on the results. Hospital use only.
  4. Biosearch S.A. (sponsor-investigator Olivares Martín M); ClinicalTrials.gov. Infant Colic Treatment With Probiotics (NCT03467334). ClinicalTrials.gov. 2019;First submitted February 8, 2018; study start May 31, 2017; last update July 22, 2019; no results posted..SourceUsed to support: Not PubMed-indexed (trial registry record, read 2026). Registration of the colic trial, filed about 8 months after it started. Lists crying time in minutes per day at 4 weeks as the primary outcome, 156 infants enrolled, simethicone as the active comparator, and masking of investigators and outcome assessors. It gives the CECT7263 arm as 100 million CFU a day, while the paper reports 200 million. The sponsor-investigator was the head of research at Biosearch S.A.; collaborators were the European Regional Development Fund and a Spanish science ministry.
  5. Jiménez E, Villar-Tajadura MA, Marín M, Fontecha J, Requena T, Arroyo R, Fernández L, Rodríguez JM. Complete genome sequence of Bifidobacterium breve CECT 7263, a strain isolated from human milk. J Bacteriol. 2012;194(14):3762-3. doi: 10.1128/JB.00691-12.PubMedUsed to support: Genome announcement from Complutense University of Madrid and CIAL researchers reporting the complete annotated genome of B. breve CECT 7263, a strain isolated from human milk. A laboratory paper, not a trial.
  6. Martínez N, Luque R, Olivares MM, Margolles A, Bañuelos O. Resequencing the Genome of Bifidobacterium breve Strain CECT7263. Genome Announc. 2017;5(18):e00299-17. doi: 10.1128/genomeA.00299-17.PubMedUsed to support: Second genome sequence of CECT7263, made to study its earlier reported resistance to streptomycin, clindamycin and erythromycin; no plasmids were found. The full text states that three authors are employees of Biosearch S.A., owner of a patent application including the strain, and that the work was funded by an Andalusian grant co-financed by the European Regional Development Fund. Laboratory work.
  7. Martínez N, Luque R, Milani C, Ventura M, Bañuelos O, Margolles A. A Gene Homologous to rRNA Methylase Genes Confers Erythromycin and Clindamycin Resistance in Bifidobacterium breve. Appl Environ Microbiol. 2018;84(10):e02888-17. doi: 10.1128/AEM.02888-17.PubMedUsed to support: Laboratory study: CECT7263 shows atypical resistance to the antibiotics erythromycin and clindamycin, traced to an uncommon gene sitting in a putative genomic island. The gene moved resistance into a sensitive B. breve strain when cloned, but in vitro conjugation tests did not detect transfer to other bacteria. Two authors were from Biosearch S.A.
  8. Robles-Vera I, de la Visitación N, Toral M, Sánchez M, Romero M, Gómez-Guzmán M, Yang T, Izquierdo-García JL, Guerra-Hernández E, Ruiz-Cabello J, Raizada MK, Pérez-Vizcaíno F, Jiménez R, Duarte J. Probiotic Bifidobacterium breve prevents DOCA-salt hypertension. FASEB J. 2020;34(10):13626-13640. doi: 10.1096/fj.202001532R.PubMedUsed to support: Animal study in rats made hypertensive with a steroid and salt: 5 weeks of CECT7263 prevented the rise in systolic blood pressure, raised acetate-producing gut bacteria and gut acetate, improved colon barrier markers and blood vessel relaxation; acetate alone mimicked these effects. Rat data only.
  9. Robles-Vera I, Toral M, de la Visitación N, Sánchez M, Gómez-Guzmán M, Romero M, Yang T, Izquierdo-Garcia JL, Jiménez R, Ruiz-Cabello J, Guerra-Hernández E, Raizada MK, Pérez-Vizcaíno F, Duarte J. Probiotics Prevent Dysbiosis and the Rise in Blood Pressure in Genetic Hypertension: Role of Short-Chain Fatty Acids. Mol Nutr Food Res. 2020;64(6):e1900616. doi: 10.1002/mnfr.201900616.PubMedUsed to support: Animal study in spontaneously hypertensive rats: long-term CECT7263 or L. fermentum CECT5716 each raised butyrate-producing gut bacteria, lowered blood endotoxin and prevented the rise in blood pressure, as did butyrate or acetate. Rat data only.
  10. National Center for Complementary and Integrative Health (NCCIH). Probiotics: What You Need To Know. NCCIH, National Institutes of Health. 2019;Web page, updated August 2019 (accessed 2026)..SourceUsed to support: Not PubMed-indexed (US government consumer page). States that the risk of harmful effects from probiotics is greater in people with severe illnesses or compromised immune systems, that severe or fatal infections have been reported in premature infants given probiotics (subject of a 2023 FDA warning), and that some products contain microorganisms not listed on the label.
  11. Food and Drink Technology. Kerry completes acquisition of Spanish Biosearch Life. Food and Drink Technology. 2021;News article, July 12, 2021..SourceUsed to support: Not PubMed-indexed (trade news). Reports that Kerry completed its acquisition of Biosearch Life, a Granada, Spain company known for probiotics derived from human breast milk, sold under the Hereditum name, along with botanical extracts and omega-3 oils. Source for the strain's current owner; the article does not name individual strains.