MedTrace Logo

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

NCT04768387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-02-24

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome Mixed

Interventions

DIETARY_SUPPLEMENT

Personalized microbiome diet

The personalized nutrition model estimates the optimal micronutrient compositions for a required microbiome modulation. In this study, we computed the microbiome modulation needed for an IBS case, based on the IBS-indices generated by the machine learning models. According to that, the baseline microbiome compositions are perturbed randomly with a small probability p. Perturbed profiles are accepted with a probability proportional to the decrease in the IBS-index as suggested by Metropolis sampling. This Monte-Carlo random walk in the microbiome composition space is expected to meet a low IBS-index microbiome composition nearby the baseline microbiome composition of the patient with a minimal modulation. The personalized nutrition model, then, estimates the optimized nutritional composition needed for this individual, expecting to drive the IBS-index to lower values.

Sponsors & Collaborators

  • ENBIOSIS BIOTECHNOLOGIES

    collaborator INDUSTRY

  • TC Erciyes University

    collaborator OTHER

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2020-11-16
Completion
2021-01-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT04768387 on ClinicalTrials.gov