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Effect of Microbiome Modulation by Diet in Functional Constipation

NCT05429333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-23

No results posted yet for this study

Summary

Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.

Conditions

  • Constipation - Functional

Interventions

OTHER

Artificial intelligence-assisted personalized diet

The AI-based nutritional recommendations system is based on the eating rates of the individual in a certain period, to ensure the homeostasis of the microbiome and increase the microbial diversity. After the microbiome analysis reports of the study group are released, a 6-week diet was designed regarding AI-based food scores specific to constipated individuals in accordance with the individual's lifestyle and comorbidities. Diet lists are updated according to the individual's feedback, recovery level, and wishes with weekly meetings.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-12-27
Completion
2021-12-27

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT05429333 on ClinicalTrials.gov