The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome

NCT04760353 | Completed

• 1 other identifier: Omni Stress 1.1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the current study is to evaluate the effect of a probiotic mixture on the adequate relief and faecal microbiota in obese patients with irritable bowel syndrome

Conditions

IBS - Irritable Bowel Syndrome; Obesity

Keywords

IBS; Obesity; microbiota

Outcome Measures

Primary Outcomes (1)

• Adequate relief

  Adequate relief (AR) related question of overall IBS symptoms "In the past 7 days have you had adequate relief of your IBS pain and discomfort?" which will be assessed weekly for 10 weeks (starting with 0 week till 10th week). A responder is defined as a patient who experiences AR (answers YES to AR related question) for at least 50% of the 10-week study period (5 of the 10 weekly assessments). 10-point analog scale will be used for the measurement of response rate among patients in each group.

  eight weeks

Secondary Outcomes (1)

• The fecal flora compositions

  eight weeks

Other Outcomes (3)

• IBS Severity

  eight weeks

• IBS QOL

  eight weeks

• Psychological distress

  eight weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

one powder portion bag of the probiotic mixture (OMNi-BiOTiC STRESS) containing 9 human bacterial strains \[Lactobacillus casei W56, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Bifidobacterium lactis W51 Bifidobacterium lactis W52, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactobacillus plantarum W62, Bifidobacterium bifidum W23, with at least 7,5 billion CFU per one dose (3 g) and 15 billion CFU per two doses (6 g)\] and vitamin B (B2, B6, B12), self-administered orally twice a day for 8 weeks

Dietary Supplement: Probiotic mixture (OMNi-BiOTiC STRESS)

Placebo

PLACEBO COMPARATOR

one powder portion bag self-administered orally twice a day for 8 weeks, identical in all aspects (organoleptic) as investigational product (IP) but containing excipient only. * Powder portion bags are suitable for participants with intolerance to yeasts or lactose * Each patient will receive a container with 112 powder portion bags (IP or placebo depending on the randomization) at the randomization period (0 weeks).

Other: Placebo

Interventions

Probiotic mixture (OMNi-BiOTiC STRESS) DIETARY_SUPPLEMENT

OMNi-BiOTiC STRESS containing 9 human bacterial strains \[Lactobacillus casei W56, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactobacillus plantarum W62, Bifidobacterium bifidum W23, with at least 7,5 billion CFU per one dose (3 g) and 15 billion CFU per two doses (6 g)\] and vitamin B (B2, B6, B12),

Probiotic

Placebo OTHER

one powder portion bag self-administered orally twice a day for 8 weeks, identical in all aspects (organoleptic) as investigational product (IP) but containing excipient only. * Powder portion bags are suitable for participants with intolerance to yeasts or lactose * Each patient will receive a container with 112 powder portion bags (IP or placebo depending on the randomization) at the randomization period (0 weeks).

Placebo

Eligibility Criteria

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

You may qualify if:

• Obese \[Body mass index (BMI) ≥30\] men or women with confirmed IBS (all subtypes based on Rome IV Diagnostic Criteria for IBS) aged between 18 and 65 years.
• Written informed consent.

You may not qualify if:

• Pregnancy or lactation
• Severe systemic illness \[cancer, gastrointestinal illness (e.g., colitis, Crohn's disease, celiac disease, recurrent diverticulitis), chronic renal failure, an endocrine disorder, metabolic disorder, angina, congestive heart failure, uncontrolled hypertension\] or severely impaired general health
• Organic abnormality which is excluded by full blood count, C-reactive protein or erythrocyte sedimentation rate, and thyroid-stimulating hormone for constipated IBS participants. To exclude other organic lower gastrointestinal disease faecal calprotectin will be checked, and celiac test and colonoscopy will be performed if needed.
• Previous abdominal surgery except for appendectomy, cholecystectomy and abdominal wall hernia repair
• History of psychiatric disorder
• History of participation in another clinical trial within 3 months before the onset of this trial
• Medications that could affect the outcomes: oral steroid, sulfasalazine, cholestyramine, misoprostol and probiotics usage 3 months prior to and during the study; and antacids with magnesium or aluminium usage during the study

Sponsors & Collaborators

• University Hospital Rijeka: lead
• Institute AllergoSan: collaborator

Study Sites (2)

Clinical Hospital Centre

Rijeka, Croatia, 51000, Croatia

Location

University Hospital Rijeka

Rijeka, Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Obesity

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GORAN HAUSER, MD, PhD

  KBC Rijeka; Medicinski fakultet Sveučilišta u Rijeci

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 18, 2021
• Study Start: November 10, 2021
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after enrollment, 50% of patients and will be available 6 months after study termination
• Access Criteria: Patients, Ethic committee members, regulatory organisations

Locations

CR (2)