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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT05656391

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis in Remission	Dietary Supplement: Treatment vs control bread	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 16, 2019

Actual Primary Completion Date :

Aug 16, 2021

Actual Study Completion Date :

Aug 16, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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