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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis in Remission
• Intervention / Treatment: Dietary supplement: Treatment vs control bread

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Girona, Catalonia, Spain, 17007
      • Hospital Doctor Josep Trueta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment bread; Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques	Dietary supplement: Treatment vs control bread; Consumption of 200 grams per day of either treatment or control bread for eight weeks
Placebo Comparator: Control bread; Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques	Dietary supplement: Treatment vs control bread; Consumption of 200 grams per day of either treatment or control bread for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IBS-like symptomatology	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.	Measurements were assessed at baseline (T0) and eight weeks (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the abundance of bacterial markers	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	Measurements were assessed at baseline (T0) and eight weeks (T1)

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Investigators: Principal Investigator: Xavier Aldeguer, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI)

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Irritable Bowel Syndrome; Colitis; Colitis, Ulcerative; Dysbiosis
• Other Study ID Numbers: RTC-2017-CU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No