Efficacy of AI-assisted personalized microbiome modulation by diet in functional constipation: a randomized controlled trial

Abstract

Background: 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. Methods: Between December 2020 December 2021, 50 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. Results: The mean age of the overall cohort (n= 45) was 31.5 years with 88.9% female predominance. The customized diet developed for subjects on the study arm resulted in a 2.5 fold increase in CBMpW after 6 weeks (1.7 vs. 4.3). The proportion of the study group patients with CBMpW>3 was 83% at the end of the study and the satisfaction score was increased 4 fold from the baseline (3.1 to 10.7 points). More than 50% improvement in PAC-QoL scores was observed in 88% of the study cohort compared to 40% in the control group (p: 0.001). Conclusion: The AI assisted customized diet based on individual microbiome analysis performed significantly better compared to the conventional therapy based on patient-reported outcomes in the treatment of functional constipation.

Competing Interest Statement

The authors declare no conflict of interest; however, the cost of the kits and microbiome analysis was funded by Enbiosis Biotechnology.

Clinical Trial

NCT05429333

Funding Statement

This study did not receive any funding however, the cost of the kits and microbiome analysis was funded by Enbiosis Biotechnology.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Institutional Ethics Committee of Istanbul Medipol University Ethical Committee (Approval no. 10840098-772.02-E.47859) and conducted in line with the Declaration of Helsinki.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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