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Carbohydrate Reduction and Impact on Gastrointestinal System (CRAIGS)

1 novembre 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 )

Tipo di studio

Interventistico

Iscrizione (Effettivo)

65

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Regno Unito, NG7 2UH
        • Nottingham Digestive Diseases Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Low FODMAP Diet
Both arms will receive the intervention but at different time points.
Comparatore placebo: 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.
Altro: Low FODMAP Diet
Both arms will receive the intervention but at different time points.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adequate symptom relief between cases and controls
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in colonic volume between cases and controls from baseline
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Nottingham

Collaboratori

King's College London

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2016

Completamento primario (Effettivo)

1 luglio 2017

Completamento dello studio (Effettivo)

1 agosto 2017

Date di iscrizione allo studio

Primo inviato

18 agosto 2017

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2018

Primo Inserito (Effettivo)

2 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 novembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2018

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 15081

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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