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Clinical Trial
. 2020 Dec;11(12):e00276.
doi: 10.14309/ctg.0000000000000276.

Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial

Olafur S Palsson  1 , Anne Peery  1 , Dorthe Seitzberg  2 , Ingvild Dybdrodt Amundsen  2 , Bruce McConnell  2 , Magnus Simrén  1   3
Affiliations
Clinical Trial

Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial

Olafur S Palsson et al. Clin Transl Gastroenterol. 2020 Dec.

Abstract

Introduction: Treatment options for irritable bowel syndrome (IBS) are limited, causing many patients to remain symptomatic. This study assessed the potential of human milk oligosaccharides (HMOs) to normalize bowel habits. Secondary outcomes included IBS severity and health-related quality of life.

Methods: This multicenter, open-label trial recruited patients with IBS from 17 sites across the United States. Patients received daily orally administrated 5-g intervention of the HMOs 2'-fucosyllactose and lacto-N-neotetraose in a 4:1 mix. Bowel habits, IBS symptoms, and quality of life were assessed at baseline and every 4 weeks during the 12-week intervention.

Results: A total of 317 patients (70.7% women; mean age of 44.0 years, range 18-93 years) received the trial product, and 245 patients completed the trial according to protocol. Patients had a significant improvement from baseline to 12 weeks in total percentage of bowel movements with abnormal stool consistency (mean and [95% confidence interval]: 90.7 [88.9-92.9] vs 57.2% [53.9-60.5], P < 0.0001), overall IBS Symptom Severity Score (323 [314-332] vs 144 [133-155], P < 0.0001) and health-rela,ted quality of life (50.4 [48.0-52.8] vs 74.6 [72.3-76.9], P < 0.0001). Improvement was similar across IBS subtypes. Symptoms improved most in the first 4 weeks of intervention. The most common side effects were mild gastrointestinal symptoms such as flatulence, abdominal pain and discomfort, and distension.

Discussion: Supplementation with 2 selected HMOs improves IBS symptoms and quality of life without substantial side effects. These promising results suggest that this novel approach to IBS should be confirmed in a randomized, placebo-controlled trial.

Trial registration: ClinicalTrials.gov NCT03550742.

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Conflict of interest statement

Guarantor of the article: Olafur S. Palsson, PsyD.

Specific author contributions: O.S.P., M.S., and B.M.: contributed in designing the trial. O.S.P.: responsible for data collection and database cleaning and analyzed the data. O.P. and I.D.A.: prepared the manuscript. All authors had full access to the study data, had input to the content of the manuscript, contributed in finalizing the manuscript, and approved the final version for submission.

Financial support: The trial was sponsored by Glycom, Inc., LA. The trial sponsor was involved in designing the trial and writing of the manuscript.

Potential competing interests: O. S. Palsson has received research support from Glycom and the Rome Foundation and served as Consultant/Advisory Board Member for Ironwood and metaMe Health. A. Peery declares no conflict of interest. D. Seitzberg, I. D. Amundsen, and B. McConnell are employed at Glycom A/S, Denmark. M. Simrén has received unrestricted research grants from Danone and Ferring Pharmaceuticals and served as a Consultant/Advisory Board member for AstraZeneca, Danone Nutricia Research, Nestlé, Almirall, Allergan, Albireo, Genetic Analysis AS, Biocodex, Glycom, Arena, and Shire and as a speaker for Tillotts, Takeda, Menarini, Kyowa Kirin, Allergan, Shire, Biocodex, Alimentary Health, AlfaSigma, and Almirall.

ClinicalTrials.gov identifier: NCT03550742.

Figures

Figure 1.
Figure 1.
Patient flow. ITT, intention-to-treat; PP, per protocol.
Figure 2.
Figure 2.
Changes in total % of abnormal consistency stools (Bristol Stool Form Scale) during 12 weeks of daily supplementation of a 5-g mix of 2'-fucosyllactose and lacto-N-neotetraose. *Significantly reduced total % of abnormal stools (diarrhea + constipation) compared with baseline at P < 0.0001.
Figure 3.
Figure 3.
Changes in the overall IBS Symptom Severity Score during 12 weeks of daily supplementation with a 5-g mix of 2'-fucosyllactose and lacto-N-neotetraose in the different IBS subtypes. *Significantly different from baseline at P < 0.0001. Error bars: 95% confidence interval. IBS, irritable bowel syndrome; IBS-C, constipation-predominant IBS; IBS-D, diarrhea-predominant IBS; IBS-M, alternating/mixed-pattern IBS.
Figure 4.
Figure 4.
Changes in (a) abdominal pain severity (0–100 scale), (b) number of days with abdominal pain (out of 10 days), and (c) bloating severity (0–100 scale) during 12 weeks of daily supplementation with a 5-g mix of 2'-fucosyllactose and lacto-N-neotetraose in the different IBS subtypes. All subtypes and the overall sample were significantly improved on all these parameters at 12 weeks. *Significantly different from baseline at P < 0.0001. Error bars: 95% confidence interval. IBS, irritable bowel syndrome; IBS-C, constipation-predominant IBS; IBS-D, diarrhea-predominant IBS; IBS-M, alternating/mixed-pattern IBS.
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