Popular gut probiotic, Activia, completely craps out in randomized controlled trial (Oct 2024, n=228) Eight-Week Supplementation With Bifidobacterium lactis HN019 and Functional Constipation. A Randomized Clinical Trial Probiotics

[Michael Harrop]

• https://arstechnica.com/health/2024/10/popular-gut-probiotic-completely-craps-out-in-randomized-controlled-trial/
• https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2824333

In a randomized controlled trial, the probiotic Bifidobacterium animalis subsp. lactis—used in many probiotic products, including Dannon's Activia yogurts—did nothing to improve bowel health in people with constipation

For the new study, researchers in China recruited 228 middle-aged adults, 85 percent of whom were women. The participants, all from Shanghai, were considered healthy based on medical testing and records, except for reporting functional constipation.

The participants were randomized to take either a placebo (117 participants) or the probiotic (112 participants) every day for eight weeks.

In 2010, the Federal Trade Commission and 39 state attorneys general announced a $21 million settlement with Dannon over, in part, the false claim that Activia could treat irregularity. In its marketing—memorable for including a television commercial with actor Jamie Lee Curtis—Dannon indicated that Activia's gut benefits were backed by data. But they were not. In the settlement, Dannon agreed to drop the unsupported health claims. The company also paid $45 million to settle a class-action lawsuit over the false advertising.

Dannon still sells Activia products, making the softer claim that they "help support gut health."

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Key Points​

Question What is the effect of 8 weeks of treatment with at least 4.69 × 109 colony-forming units/d of Bifidobacterium animalis subsp lactis HN019 on complete spontaneous bowel movements (CSBMs) in individuals with constipation?

Findings This triple-blindrandomized clinical trial including 229 participants in 5 hospitals in China demonstrated that CSBMs were improved in both the placebo and HN019 groups, with no meaningful differences between groups.

Meaning Daily consumption of B lactis HN019 at the tested dose of 4.69 × 109 CFU did not outperform placebo to increase CSBMs.

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Abstract​

Importance Probiotic supplementation may improve bowel movements. However, large, properly designed studies are lacking.

Objective To evaluate the potential benefit of Bifidobacterium animalis subsp lactis HN019 on constipation, expressed as complete spontaneous bowel movements (CSBMs).

Design, Setting, and Participants This randomized triple-blind placebo-controlled clinical trial with 2 weeks of run-in and 8 weeks of intervention was conducted from December 25, 2020, to February 28, 2022, at 5 hospitals in Shanghai, China. Participants included healthy volunteers with functional constipation according to Rome III criteria, 18 to 70 years of age, and a body mass index (calculated as the weight in kilograms divided by the height in meters squared) of less than 30.0. Eligibility after the run-in phase required the randomized participants to have 3 or fewer CSBMs/wk. Data were analyzed from September 29, 2022, to March 23, 2023, and reported as intention to treat.

Intervention Participants were randomized to receive probiotic (B lactis HN019, 7.0 × 109 colony forming units (CFU)/d in maltodextrin at the start of the study and 4.69 × 109 CFU/d at the end of the study or maltodextrin placebo once a day for 8 weeks.

Main Outcomes and Measures Primary outcome was change in CSBMs. Secondary outcomes included use of rescue medication, stool consistency, degree of straining for each bowel movement, abdominal pain, and bloating. Further, dietary habits and physical activity were recorded. Fecal samples were analyzed for moisture content, short-chain fatty acids, branched-chain fatty acids, microbiota composition, and calprotectin.

Results Of the 283 individuals assessed for eligibility, 229 were randomized to either the placebo (n = 117) or the HN019 (n = 112) group. One participant in the placebo group discontinued due to COVID-19 restrictions. The 229 participants (194 [84.7% female) had a median age of 45 (38-52) years, mean (SD) BMI of 22.8 (2.5), and a mean (SD) of 0.77 (1.0) CSBM/wk. There was no difference in the change of weekly CSBMs from baseline to the end of study between the HN019 (least-square mean change, 0.80 [95% CI, 0.54-1.05]) and placebo (least-square mean change, 0.66 [95% CI, 0.41-0.90]) groups.

Conclusions and Relevance Although probiotics have been reported to improve bowel function, this large, well-conducted randomized clinical trial did not confirm such results. Daily consumption of B lactis HN019 at the tested dose of 4.69 × 109 CFU did not outperform placebo to increase CSBMs.

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