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临床试验/NCT04768387
NCT04768387已完成不适用

An Open-labelled Interventional Study With 25 IBS-M Patients in Which Group 1 (n=14) Followed Six Weeks of AI-based Microbiome Diet and Group 2 (n=11) Followed Standard IBS Diet

Gazi University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
IBS-SSS change

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

IBS-SSS change

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarkan Karakan

Professor Doctor of Gastroenterology

Gazi University

研究点 (1)

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