NCT04768387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 19, 2021

Last Update Submit

February 22, 2021

Conditions

Irritable Bowel Syndrome Mixed

Outcome Measures

Primary Outcomes (1)

  • IBS-SSS change

    Change in IBS-SSS scores according to ROME IV criteria were assessed.

    Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts

Study Arms (2)

Personalized microbiome diet

EXPERIMENTAL

Six weeks of AI-based microbiome diet was introduced.

Dietary Supplement: Personalized microbiome diet

Standard IBS diet

ACTIVE COMPARATOR

Six weeks of standard IBS diet was introduced.

Dietary Supplement: Personalized microbiome diet

Interventions

Personalized microbiome dietDIETARY_SUPPLEMENT

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.

Also known as: ARTIFICIAL INTELLIGENCE BASED PERSONALIZED DIET
Personalized microbiome dietStandard IBS diet

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor of Gastroenterology

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 24, 2021

Study Start

October 5, 2020

Primary Completion

November 16, 2020

Study Completion

January 15, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

TU(1)