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

Gazi University

Status: Completed

Conditions: Irritable Bowel Syndrome Mixed

Treatments: Dietary Supplement: Personalized microbiome diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04768387

EnbiosisIBS

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Personalized microbiome diet

Experimental group

Description:

Six weeks of AI-based microbiome diet was introduced.

Treatment:

Dietary Supplement: Personalized microbiome diet

Standard IBS diet

Active Comparator group

Description:

Six weeks of standard IBS diet was introduced.

Treatment:

Dietary Supplement: Personalized microbiome diet