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Carbohydrate Reduction and Impact on Gastrointestinal System (CRAIGS)

2018년 11월 1일 업데이트: University of Nottingham

A Pilot Randomised Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Gastrointestinal Form and Symptoms in Irritable Bowel Syndrome Patients

Title :

A pilot single blind randomised controlled trial of the effect of a diet low in poorly digested carbohydrates on gastrointestinal form and symptoms in irritable bowel syndrome patients

Acronym: CRAIGS

Short title: Carbohydrate reduction and impact on gastrointestinal system Chief Investigator: Prof Robin Spiller

Objectives:

The purpose of this study is to:

  • Investigate the proportion of patients with Irritable Bowel Syndrome who report moderate or substantial improvement in their symptoms after 2 weeks of following a diet low in Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs) compared to patients who are on their habitual diet.
  • Determine the difference in colonic volume of IBS patients receiving immediate low FODMAP dietary intervention after 2 weeks compared to patients who are not on the diet (delayed dietary intervention).
  • Investigate the changes in self-reported food intolerance that occurs before dietary intervention.

Trial Configuration:

2-arm, parallel group, randomised, controlled trial

Setting :

Research clinic within NIHR Biomedical Research Unit, Secondary care

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

TRIAL / STUDY OBJECTIVES AND PURPOSE

The trial aims to investigate the effect of a diet low in FODMAPs on colonic morphology as well as in improving symptoms of irritable bowel syndrome (IBS).

This mechanistic information, along with the clinical data, will allow planning of larger, multi-centre studies of the low FODMAP diet in similar patients.

HYPOTHESES

  • Patients on a low FODMAP diet for 2 weeks will have a decreased fasting colonic volume measured by Magnetic Resonance Imaging (MRI) compared to participants who have not started the diet.
  • Patients with IBS are more likely to report a clinically important improvement in symptoms following the low FODMAP diet (immediate intervention) compared to those on their habitual diet (delayed intervention).

PRIMARY OBJECTIVE • To compare the proportion of IBS patients reporting a clinically important improvement in symptoms following a low FODMAP diet for 2 weeks against IBS patients who are on their habitual diet.

SECONDARY OBJECTIVES

• Determine the difference in fasting colonic volume of IBS patients receiving low FODMAP dietary intervention after 2 weeks compared to those on habitual diet.

TRIAL DESIGN

This will be a pilot single-blind, randomised, controlled trial (RCT). Since some activity will take place on the University of Nottingham this will be a multi-centre study.

All participants will receive advice from a dietitian on the low FODMAP diet. They will be randomised to one of two parallel treatment arms:

  1. Low FODMAP dietary advice (immediate intervention)
  2. Habitual diet (control - delayed intervention )

연구 유형

중재적

등록 (실제)

65

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 영국
    • Nottinghamshire
      • Nottingham, Nottinghamshire, 영국, NG7 2UH
        • Nottingham Digestive Diseases Centre

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged 18 and above
  • Able to give informed consent
  • Previous Diagnosis of IBS by medical practitioner
  • Meeting ROME III criteria for IBS
  • Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
  • Full blood count test does not indicate Anaemia

Exclusion Criteria:

  • Inclusion

    • Aged 18 and above
    • Able to give informed consent
    • Previous Diagnosis of IBS by medical practitioner
    • Meeting ROME III criteria for IBS
    • Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
    • Full blood count test does not indicate Anaemia

Exclusion

  • Children (<18 years)

  • History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:

    • Inflammatory Bowel Disease
    • Coeliac Disease
    • Pancreatitis
    • Gallstone disease (biliary colic, cholecystitis)
    • Diverticulitis
    • Cancer of the gastrointestinal tract
  • Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
  • Intestinal stoma
  • Limited understanding of English
  • Pregnancy declared by the candidate
  • Red flag symptoms such as rectal bleeding, family history of bowel or ovarian cancer, a change in bowel habit to looser and/or more frequent stools persisting for more than six weeks in a person aged over 60 years.
  • Investigations showing positive tissue transglutaminase (tTG) IgA antibodies
  • Anaemia confirmed by full blood count test
  • Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
  • Use of antibiotics in the preceding four weeks other than for treatment of index infection.
  • Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
  • Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding
  • Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. chaotic lifestyle related to substance abuse
  • Dietary practice not compatible with safe implementation of the trial diet e.g.veganism
  • Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g. end-stage kidney disease, diabetes
  • Participants taking prebiotic/probiotic

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Immediate Intervention
Participants in this arm will receive an immediate low FODMAP dietary intervention on their second visit after they have been screened, consented and enrolled during visit 1.
다른: Low FODMAP Diet
Both arms will receive the intervention but at different time points.
위약 비교기: Delayed Intervention
Participants in this arm will receive a delayed Low FODMAP dietary intervention during their third visit after they have been been screened, consented and enrolled during visit 1.
다른: Low FODMAP Diet
Both arms will receive the intervention but at different time points.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adequate symptom relief between cases and controls
기간: Assessed in cases on their last day of the intervention (2 weeks after dietary change). Assessed in controls before they began their intervention (between 1-2 weeks before dietary changes)
Adequate symptom relief assessed by questionnaire after intervention in cases and before intervention in cases
Assessed in cases on their last day of the intervention (2 weeks after dietary change). Assessed in controls before they began their intervention (between 1-2 weeks before dietary changes)

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in colonic volume between cases and controls from baseline
기간: Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)
A change in colonic volume measured in milliliters (ml) from baseline and after intervention in cases. This will compared with a change in colonic volume from baseline and before intervention in controls.
Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)
Changes in fermentation between cases and controls
기간: Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)
A change in breath hydrogen concentration measured in parts per million (ppm) from: baseline and after intervention (cases) ii) from baseline and before intervention (controls)
Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Nottingham

협력자

King's College London

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 1월 1일

기본 완료 (실제)

2017년 7월 1일

연구 완료 (실제)

2017년 8월 1일

연구 등록 날짜

최초 제출

2017년 8월 18일

QC 기준을 충족하는 최초 제출

2018년 11월 1일

처음 게시됨 (실제)

2018년 11월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 11월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 11월 1일

마지막으로 확인됨

2018년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 15081

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과민성 대장 증후군에 대한 임상 시험

Low FODMAP Diet에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

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약물 개입

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스폰서 / 협력자

위치

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