The Effect of AI-based Microbiome Diet on IBS-M Symptoms

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome Mixed
• Interventions: Dietary Supplement: Personalized microbiome diet

• Registration Number: NCT04768387
• Lead Sponsor: Gazi University

Brief Summary

This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.

Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Primary Completion: 2020-11-16
• Study Completion: 2021-01-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Diagnosed with IBS by a medical doctor.
• BMI between 18.5-39.9 kg/m2
• No hospitalization in the last 12 months.
• No antibiotics use in the last 6 months.
• No cancer diagnosis by a medical doctor.
• No chronic complex diseases including diabetes and hypertension.

Exclusion Criteria

• Not being diagnosed with IBS.
• Having a diagnosed chronic disease.
• Having a diagnosed mental or psychiatric disorder .
• Having endocrinal disorders.
• Being pregnant.
• Antibiotics use in the last 6 months.
• Hospitalization history in the last 12 months.
• Drug use.
• Being morbid obese.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized microbiome diet	Personalized microbiome diet	Six weeks of AI-based microbiome diet was introduced.
Standard IBS diet	Personalized microbiome diet	Six weeks of standard IBS diet was introduced.

Primary Outcome Measures

Name	Time	Method
IBS-SSS change	Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts	Change in IBS-SSS scores according to ROME IV criteria were assessed.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey