Human Milk Oligosaccharides (HMOs) for Irritable Bowel Syndrome (IBS)

NCT05205785 | Terminated

• 1 other identifier: 2021-07-21-HMOS
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).

Conditions

Irritable Bowel Syndrome; IBS - Irritable Bowel Syndrome

Keywords

Human Milk Oligosaccharides; HMOs

Outcome Measures

Primary Outcomes (2)

• Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group.

  Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass \[classified as severe constipation\]; Type 7 = watery, entirely liquid stool \[classified as severe diarrhea\]). Types 1 and 2 would be considered to suggest severe and mild diarrhea, respectively. Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively. This endpoint will compare the proportion of participants experiencing constipation and diarrhea between the groups

  Baseline (2 week run in period) to end of intervention (weeks 11 + week 12)

• Absolute change in the pain severity score (IBS-SSS) in the active product compared to placebo group.

  The IBS Symptom Severity Scale (IBS-SSS) contains a pain subscale which asks participants to rate abdominal pain the past 10 days on a scale from 0 to 100, with 0 meaning "no pain" and 100 meaning "very severe pain". The minimum score is 0 and the maximum achievable score is 100.

  Baseline (Visit 2) to Week 12 (Visit 3)

Secondary Outcomes (3)

• Absolute change in total IBS severity score in the active product compared to placebo group.

  Baseline (Visit 2) to Week 12 (Visit 3)

• Absolute change in total IBS Quality of Life (IBS-QOL) score in the active product compared to placebo group.

  Baseline (Visit 2) to Week 12 (Visit 3)

• Relative change in abundance of fecal Bifidobacteria spp in the active product compared to placebo group.

  Baseline (Visit 2) to Week 12 (Visit 3)

Other Outcomes (20)

• Absolute change in GSRS-IBS (Gastrointestinal Symptom Rating Scale-IBS) scores.

  Baseline (Visit 2) to Week 12 (Visit 3)

• Abdominal pain responder rate.

  Baseline (2-week run-in period) to the last two weeks of intervention (week 11+12)

• Absolute change in BSFS (Bristol Stool Form Scale) score.

  Baseline (2-week run-in period) to the last two weeks of intervention (week 11+12)

Study Arms (2)

Human Milk Oligosaccharide (HMO) mix

EXPERIMENTAL

The HMO blend to be used in this trial is a mix of the three milk oligosaccharides produced by fermentation of lactose. The blend is provided as white powder and mixed in a single serve stick packs containing 5.5 g of HMOs. The final product contains less than 0.03 g lactose per serving. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

Dietary Supplement: Human Milk Oligosaccharide Mix

Placebo

PLACEBO COMPARATOR

The placebo to be used in this trial is 5.5 g of powdered dextrose powder in a single-serve stick pack. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

Other: Placebo

Interventions

Human Milk Oligosaccharide Mix DIETARY_SUPPLEMENT

Subjects takes 5.5 g of powder mixed in water once a day for 12 weeks.

Also known as: HMOs

Human Milk Oligosaccharide (HMO) mix

Placebo OTHER

The placebo to be used in this trial is 5.5 g of powdered dextrose powder in a single-serve stick pack. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained before any trial related assessments are performed.
• Male or female aged ≥18 years at the time of consent.
• a. Female participants of child-bearing potential (females who are post-menopausal, i.e., when there has been no menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration). iv. Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent. v. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration). vi. Contraceptives must be effective before the randomization visit. However, national requirements should always be followed.
• IBS-D or IBS-C or IBS-M according to Rome IV criteria. This will be established by using the IBS Module of the Rome IV Diagnostic Questionnaire, and requires recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following:
• Related to defecation (may be increased or unchanged by defecation) on at least 30% of pain instances in past 3 months.
• Associated with a change in stool frequency (on at least 30% of pain instances in past 3 months).
• Associated with a change in stool form or appearance (on at least 30% of pain instances in past 3 months).
• Reported IBS diagnosis from a physician.
• Personal access to the internet via computer, tablet, or smart-phone.
• Be willing and able to comply with trial protocol, including entry of electronic diary data for at least 12 out of 14 diary days during the pre-randomization baseline 2-week run-in diary period (between V1 andV2).
• Scores of 1, 2, 6, or 7 on the Bristol stool scale at least twice per week \[as determined by eDiary completion between V1 and V2\].
• An average baseline of worst abdominal pain of ≥3.3 (NRS-11) during the 2-week run-in period prior to randomization \[as determined by eDiary completion between V1 and V2\].

You may not qualify if:

• The presence of any of the following criteria will exclude the participant from participating in the trial:
• Treatment with an investigational drug from another clinical trial within 30 days/5 half- lives of the drug (which ever longest) prior to screening visit.
• Any known gastrointestinal disease(s) or medical history that may interfere with the trial evaluations in the opinion of the investigator, in particular:
• Coeliac disease.
• IBD.
• Diverticulitis.
• C. difficile infection reported in the previous 2 years.
• Any clinically symptomatic biochemical or structural abnormality or active disease of the gastrointestinal tract within 6 months before screening, including daily diarrhea within two weeks prior to the screening interview or during the screening/baseline period.
• Substance abuse (within past 2 years).
• New use of antibiotics (within past 2 months), prebiotics, probiotics, or fiber supplements (within the past month).
• Hepatic dysfunction assessed as part of the blood safety panel (defined as alanine aminotransaminase/serum glutamic-pyruvic transaminase or aspartate aminotransaminase/serum glutamic-oxaloacetic transaminase \>2.5 x the upper limit of normal, or a history of hepatobiliary disease) or renal impairment (serum creatinine) \>2 mg/dl); any surgery (within a year of screening) on the stomach, small intestine, or colon (excluding appendectomy, hernia surgery not involving the GI tract, or c-section).
• Any history of pancreatitis (either acute or chronic).
• Laxative abuse (use of more than recommended dosage).
• Pregnant or lactating individuals.
• Any other gastrointestinal disease(s) or medical history that may interfere with the trial evaluations in the judgment of the investigator.

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (1)

Atlantia Clinical Trials Ltd

Cork, Cork/Munster, T23 R50R, Ireland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Martin Buckley, M.D.

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

• Seema Mody, MSc

  DSM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 25, 2022
• Study Start: March 22, 2023
• Primary Completion: March 5, 2024
• Study Completion: June 24, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)