Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
Sponsordsm-firmenich Switzerland AG

About this trial

A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)

Eligibility criteria

Qualifiers

Written and signed informed consent (will be obtained before any study-related Assessments).

Male or female aged ≥18 - 70 years at the time of consent.

Sexual abstinence.

Oral contraceptives.

Disqualifiers

Individuals with IBS-M.

Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.

Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).

Individuals with a history of surgical resection of the stomach, small intestine or large intestine.

Trial design

Treatments tested in this trial

  • MIX 1
  • MIX 2
  • Placebo

Treatment groups

402 Participants
are divided into 3 treatment groups

Sponsors and collaborators