The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS
The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients
연구 개요
상세 설명
The study will be performed on 140 subjects with verified IBS. Patients will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study patients will fill out protocols concerning Rom IV criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales. They will be examined by a physician/researcher who will complete protocols of clinical data. Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals will go through the same procedure as described above.
Study participants with IBS will thereafter be randomized to receive an alternative diet resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130), or to continue with their regular diet (control group; n=20). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses.
Statistics
To study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used, respectively.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Malmö, 스웨덴, 20502
- Deartment of INternal Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Verified IBS according to Rom IV criteria.
Exclusion Criteria:
- Serious mental or somatic disease
- Abuse
- Inability to understand he Swedish language
- Already on a diet (e.g. vegan, FODMAP, gluten-free).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Dietary intervention subject group
n=130.
Participants on low FODMAP-similar diet during 4-week study period.
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Elimination of certain products.
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간섭 없음: Control group
n=20.
Participants on traditional IBS diet during 4-week study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Genetic variation of enzymes regulating absorption of disaccharides
기간: measured at baseline
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Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
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measured at baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
기간: 4 weeks
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Changes from baseline in subjective symptoms according to the IBS-SSS.
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4 weeks
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Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
기간: 4 weeks
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Changes from baseline in subjective symptoms according to the VAS-IBS.
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4 weeks
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Gut microbiota composition
기간: 4 weeks
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Changes from baseline in fecal microbiota analysed by 16rs
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4 weeks
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Cytokines
기간: 4 weeks
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Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
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4 weeks
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microRNA expression
기간: 4 weeks
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Changes from baseline in microRNA expression will be assessed.
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4 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Bodil Ohlsson, MD, PhD, Region Skane
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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