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

Study Overview
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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.

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

Conditions
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Ulcerative Colitis in Remission

Intervention / Treatment
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* Dietary Supplement: Treatment vs control bread


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) |