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

Not Applicable

Completed

• Conditions: Ulcerative Colitis in Remission
• Interventions: Dietary Supplement: Treatment vs control bread

• Registration Number: NCT05656391
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-12-16
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Status Verified: 2022-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-18
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment bread	Treatment vs control bread	Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques
Control bread	Treatment vs control bread	Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques

Primary Outcome Measures

Name	Time	Method
Changes in IBS-like symptomatology	Measurements were assessed at baseline (T0) and eight weeks (T1)	Changes in IBS-like symptomatology were tested by IBS-Symptom Severity Score. The overall IBS-SSS score was calculated by totalling the punctuation of its five items. Each ranged from 0 to 100: (i) abdominal pain, (ii) number of days of abdominal pain during the last 10 days (number of days with abdominal pain x10), (ii) abdominal distension, (iv) satisfaction of defecatory behaviour, (v) interference of IBS symptoms in life. The possible range was then 0-500.

Secondary Outcome Measures

Name	Time	Method
Changes in the abundance of bacterial markers	Measurements were assessed at baseline (T0) and eight weeks (T1)	Shifts of abundance of Eubacteria (EUB), A. municiphila (AKK), M. smithii (MSM), Bacteroidetes (BAC), Ruminococcus sp. (RUM), F. prausnitzii (FPRA) and E. coli (ECO) levels will be measured prior (T0) and after the intervention (T1). Results will be expressed as 16S gene copies of microbes per gram of faeces

Trial Locations

Locations (1)

Hospital Doctor Josep Trueta; 🇪🇸 Girona, Catalonia, Spain