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

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ulcerative Colitis in Remission

Interventions

Treatment vs control breadDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Doctor Josep Trueta

Girona, Catalonia, Spain

Outcomes

Primary Outcomes

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.

Time frame: Measurements were assessed at baseline (T0) and eight weeks (T1)

Secondary Outcomes

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

Time frame: Measurements were assessed at baseline (T0) and eight weeks (T1)

Data from ClinicalTrials.gov

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