Benefits
Immune defense in children aged 3 to 5 (fever and cough episodes)
In a 6 month placebo-controlled trial in healthy children aged 3 to 5 at day care centers, NCFM alone twice daily was followed by 53% lower fever incidence and 41% lower cough incidence than placebo, 32% shorter symptom duration, fewer antibiotic prescriptions and fewer days absent. Runny nose incidence did not differ. The maker sponsored the trial and registered it after it ended.
Overall bowel symptom scores in adults
In 391 adults with IBS, NCFM alone at 1 or 10 billion CFU a day for 12 weeks did not beat placebo on the overall symptom severity score, the primary outcome, or on any secondary outcome. In a later subgroup analysis of people with moderate to severe pain, pain scores fell more on NCFM. The maker sponsored the trial.
Insulin sensitivity in adult men over 4 weeks
In 45 men with normal or impaired glucose tolerance or type 2 diabetes, insulin sensitivity measured by clamp stayed level over 4 weeks on NCFM but fell on placebo, a significant difference between groups. NCFM did not change inflammatory markers or the response to an endotoxin injection, a second main outcome.
Fussing and crying time in young infants
In 60 infants with colic, five drops of NCFM (1 billion CFU) a day for 28 days did not raise the share of infants whose crying time halved by day 28, the primary outcome. Crying and fussing time, infant mood and fecal calprotectin did not differ from placebo. A day 14 difference did not hold after correction for multiple comparisons.
Bloating and gas scores with NCFM blends
In 60 adults with bowel symptoms, NCFM plus B. lactis Bi-07 for 8 weeks did not beat placebo on global relief or satisfaction, the primary outcomes, but bloating scores were lower at 4 weeks. A two-strain acidophilus product of NCFM and LAFTI L10 lowered gas scores but not abdominal pain. These results belong to the blends.
Mechanism of action
Passage through the gut without lasting colonization
In 10 healthy adults taking 10 billion NCFM cells a day in skim milk for 2 weeks, the strain survived passage and changed the mix of fecal lactobacilli but did not stay once intake stopped. In a 4 week trial in men, NCFM was found in 75% of fecal samples after the course.
Pain receptor expression in the colon lining
In 20 women with mild to moderate abdominal pain, 21 days of NCFM alone raised mu-opioid receptor gene and protein expression in colon biopsies, while NCFM with B. lactis Bi-07 did not. The study had no placebo arm and was too small to judge symptoms, so this is a marker finding only.
Stomach bacteria and inflammation in cell and mouse work
In cultured human stomach cells and in mice, NCFM reduced the attachment of H. pylori and lowered inflammatory signals such as IL-8 and TNF-alpha. These are lab and animal findings from a study with authors employed by the strain's owner, and they have not been shown in people.
Genome features linked to gut survival
The complete NCFM genome, about 1.99 million base pairs with no plasmids, encodes proteins predicted to bind mucus and fibronectin, many carbohydrate transport systems and acid tolerance systems. These are predictions from the gene sequence, not measured effects in people.
Clinical trials
Randomized, double-blind, placebo-controlled three-arm trial at day care centers in Jinhua, China, from November 2005 to May 2006 (NCT00599430, registered in January 2008 after the trial ended); placebo, NCFM alone, or NCFM plus B. animalis subsp. lactis Bi-07, twice daily in milk for 6 months, with 10 billion CFU a day per the registry; the registry's single primary outcome is a general aim, to reduce flu-like and other illness symptoms, with no specific symptom measure named; the abstract reports incidence and duration of fever, cough and runny nose and does not mention a correction for multiple outcomes; Danisco was the registered sponsor and the first author worked in Danisco research and development; PubMed lists no affiliation for the other authors; only the NCFM alone arm is counted here (Leyer et al. 2009, Pediatrics)
326 healthy children aged 3 to 5 (104 placebo, 110 NCFM alone, 112 NCFM plus Bi-07).
Versus placebo, NCFM alone lowered fever incidence by 53.0% (p = 0.0085) and cough incidence by 41.4% (p = 0.027); the 28.2% lower runny nose incidence was not significant (p = 0.68). Combined fever, cough and runny nose duration fell by 32% (p = 0.0023), antibiotic use by 68.4% (p = 0.0002) and days absent from child care by 31.8% (p = 0.002). The two-strain blend arm showed larger reductions. The abstract does not report adverse event counts.
Randomized, triple-blind, placebo-controlled multicenter dose-ranging trial in Finland (NCT01728610, registered before recruitment); one capsule a day of NCFM (ATCC 700396) at 1 billion or 10 billion CFU, or microcrystalline cellulose placebo, for 12 weeks after an 8 week run-in; primary outcome change in the IBS Symptom Severity Score; sponsored by DuPont Nutrition and Health, with the product supplied by Danisco USA; five authors (Lyra, Tennilä, Tarpila, Lahtinen, Ouwehand) were present or former employees of the sponsor (Lyra et al. 2016, World J Gastroenterol)
391 adults meeting Rome III criteria for IBS were randomized; 340 completed.
The symptom severity score fell by 44.0 points on placebo, 50.8 on the low dose and 48.3 on the high dose, with no difference between groups, and secondary outcomes did not differ. In a post hoc analysis of people with moderate to severe pain at baseline, pain scores fell by 20.8, 29.4 and 31.2 points (p = 0.046, placebo versus both doses combined). Adverse events were evenly spread (81, 57 and 61 events).
Double-blind, randomized, placebo-controlled trial in Copenhagen (NCT00413348, submitted in December 2006 about a month after the listed start; the paper itself does not cite it); NCFM capsules (ATCC 700396, each about 10 billion CFU) or placebo for 4 weeks, with insulin sensitivity measured by hyperinsulinemic euglycemic clamp and the inflammatory response to an injection of E. coli endotoxin measured before and after, the two registered primary outcomes; Danisco supplied the strain and read the manuscript before submission, posing no restrictions, according to the paper; no author lists a Danisco affiliation; funded by foundations and the Danish National Research Foundation (Andreasen et al. 2010, Br J Nutr)
45 men with type 2 diabetes, impaired glucose tolerance or normal glucose tolerance.
Treatment group significantly affected the change in insulin sensitivity (p < 0.01): it fell on placebo (p = 0.03) and rose non-significantly on NCFM (p = 0.09). Baseline inflammatory markers and the inflammatory response to endotoxin were not affected. NCFM was detected in 75% of fecal samples after treatment. Three men in the NCFM group dropped out and were excluded.
Double-blind, placebo-controlled randomized trial in Goiania, Brazil (RBR-5pp4nks, registered retrospectively in September 2023); five drops a day of NCFM (1 billion CFU) or placebo for 28 days; primary outcome the share of responders, infants whose full-force crying and fussing time fell by at least 50% from baseline, at day 28; the full text names the product as a commercial DuPont Danisco NCFM drop (Flora B, Cifarma) with deposit ATCC SD-5221 and lists research scholarships from the Brazilian agencies CNPq and CAPES as funding; the authors declared no competing interests (Vaz et al. 2026, BMC Pediatr)
60 infants with colic.
The responder rate at day 28, the primary outcome, did not differ between groups (p = 0.240). A higher responder rate at day 14 in exploratory analysis (p = 0.045) weakened after correction for multiple comparisons. Fussing and crying time (p = 0.524), infant mood (p = 0.720) and fecal calprotectin (p = 0.687) did not differ. Microbiota diversity rose in the probiotic groups, a marker finding. The authors reported the strain as safe in this group.
Double-blind, randomized, two-arm, single-center study at the University of North Carolina (NCT01064661, with Danisco listed as collaborator); NCFM alone or NCFM plus B. lactis Bi-07, twice daily for 21 days at 20 billion CFU a day in total per the methods and registry; the registered primary outcome was expression of colon lining receptors involved in pain signaling, measured in sigmoidoscopy biopsies; supported by NIH grants, with research and educational support from Danisco to the university acknowledged for two authors; no author was a Danisco employee (Ringel-Kulka et al. 2014, Aliment Pharmacol Ther)
20 women aged 18 to 70 with mild to moderate abdominal pain (10 per arm).
NCFM alone, but not the blend, raised mu-opioid receptor mRNA and protein expression in colon biopsies and its downstream STAT3 signaling, while cannabinoid receptor 2 expression fell slightly. Symptoms trended toward improvement in both arms, but the study was not powered to judge them. There was no placebo arm, so this is a receptor marker result only.
Uncontrolled feeding study at the University of Minnesota; fecal lactobacilli were followed for 2 weeks before, 2 weeks during and 2 weeks after daily intake of NCFM in skim milk (10 billion viable cells a day), with 16S rDNA sequencing to identify species; there was no placebo or control group, and the abstract gives no funding statement (Sui et al. 2002, J Appl Microbiol)
10 healthy adults.
The species mix of fecal lactobacilli changed considerably while NCFM was taken, showing that it survived passage through the gut, but it did not establish itself during the 2 weeks of intake. The authors concluded that continuous intake is needed to keep a high population of the strain.