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Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis

NCT ID: NCT05656391

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2021-08-16

Brief Summary

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The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.

Detailed Description

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Conditions

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Ulcerative Colitis in Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment bread

Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques

Group Type ACTIVE_COMPARATOR

Treatment vs control bread

Intervention Type DIETARY_SUPPLEMENT

Consumption of 200 grams per day of either treatment or control bread for eight weeks

Control bread

Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques

Group Type PLACEBO_COMPARATOR

Treatment vs control bread

Intervention Type DIETARY_SUPPLEMENT

Consumption of 200 grams per day of either treatment or control bread for eight weeks

Interventions

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Treatment vs control bread

Consumption of 200 grams per day of either treatment or control bread for eight weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
* Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
* Subjects aged over 18 years
* Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) \> 175.

Exclusion Criteria

* Presence of flare-up of UC
* Coeliac disease, colectomy, or intestinal resection
* Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
* Any malignancy, pregnancy, or breastfeeding
* Intake of medication potentially influencing gastrointestinal function
* Disability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role lead

Responsible Party

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Xavier Aldeguer

Head of Gastroenterology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xavier Aldeguer

Role: PRINCIPAL_INVESTIGATOR

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)

Locations

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Hospital Doctor Josep Trueta

Girona, Catalonia, Spain

Site Status

Countries

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Spain

References

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Lluansi A, Lliros M, Carreras-Torres R, Bahi A, Capdevila M, Feliu A, Vila-Quintana L, Elias-Masiques N, Cueva E, Peries L, Torrealba L, Miquel-Cusachs JO, Sabat M, Busquets D, Lopez C, Delgado-Aros S, Garcia-Gil LJ, Elias I, Aldeguer X. Impact of bread diet on intestinal dysbiosis and irritable bowel syndrome symptoms in quiescent ulcerative colitis: A pilot study. PLoS One. 2024 Feb 16;19(2):e0297836. doi: 10.1371/journal.pone.0297836. eCollection 2024.

Reference Type DERIVED
PMID: 38363772 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RTC-2017-CU

Identifier Type: -

Identifier Source: org_study_id