Safety and Efficacy of a Probiotic Supplement in IBS-D

NCT05754177 | Completed

• 1 other identifier: ADM/CTB2022TN102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).

Conditions

Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome

Keywords

IBS; Probiotic; Irritable Bowel Syndrome; GI microbiome; Bifidobacterium

Outcome Measures

Primary Outcomes (1)

• Change in total irritable bowel syndrome symptom severity score (IBS-SSS)

  Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes

  Day 0, Day 28, Day 58 and Day 84

Secondary Outcomes (6)

• Percentage of population achieving a normal stool consistency

  Day 0, Day 28, Day 58 and Day 84

• Percentage of population without diarrhea

  Weekly

• Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score

  Day 0, Day 28, Day 58 and Day 84

• Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score

  Day 0, Day 28, Day 58 and Day 84

• Gut microbiome compositional changes

  Day 0, Day 84

Other Outcomes (3)

• Adverse Events

  Day 0, Day 84

• Stool Biochemistry

  Day 0, Day 84

• Proton Pump Inhibitor Use

  Day 0, Day 84

Study Arms (2)

Probiotic

EXPERIMENTAL

Arm receiving investigation product (probiotic)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Arm receiving placebo

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria), administered orally by 1 capsule a day, for 84 days

Probiotic

Placebo OTHER

Participants in this arm will receive an equivalent placebo for 84 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥18 to ≤ 65 years.
• Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
• i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria:
• Related to defecation
• Associated with a change in stool frequency (increase/decrease in frequency).
• Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movements categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 (constipation) on BSFS).
• Participants with an IBS-SSS score ≥ 175.
• Participants who test negative for COVID-19 by Rapid Antigen Test Device.
• Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study.
• Participants who can comply and perform the procedures as per the protocol (consumption of study products, biological sample collection procedures, and study visit schedule).
• Participants who are literate enough to understand the purpose of the study and their rights.
• Participants who are able to give written informed consent and are willing to participate in the study.

You may not qualify if:

• Participants who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed).
• Participants diagnosed with Coeliac Disease.
• Lactose intolerant participants unless on a strict lactose free diet for at least three months before screening day with persistent symptoms of IBS-D.
• Participants with a body mass index (BMI) ≥ 30 kg/m2.
• Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
• Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotics, food supplements with iron or calcium, peppermint oil, acid sequestrants (cholestyramine, Bile colestipol), introduced/active low FODMAP diet, and histamine H2-receptor antagonists/H2 blockers within six weeks prior to the screening day.
• Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks prior to the screening day.
• Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
• Participants with a history of gastrointestinal-related abdominal surgery other than hernia repair.
• Participants with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
• Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.
• Participants with a history of or complications from GI malignant tumours.
• Participants with a history of or complications from other malignant tumours in the last 5 years.
• History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints.
• Participation in other clinical studies in the last 90 days prior to screening day.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Vizera d.o.o.: collaborator

Study Sites (1)

Vizera

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: June 6, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)