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

NCT04760353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotic mixture (OMNi-BiOTiC STRESS)

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),

OTHER

Placebo

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).

Sponsors & Collaborators

  • Institute AllergoSan

    collaborator UNKNOWN

  • University Hospital Rijeka

    lead OTHER

Principal Investigators

  • GORAN HAUSER, MD, PhD · KBC Rijeka; Medicinski fakultet Sveučilišta u Rijeci

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2025-10-17
Completion
2025-10-17

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760353 on ClinicalTrials.gov