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

Ulcerative Colitis in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656391
• Other study ID #: RTC-2017-CU
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: August 16, 2021

Study information

• Verified date: December 2022
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Dysbiosis
• Irritable Bowel Syndrome
• Ulcer
• Ulcerative Colitis in Remission

Intervention

Dietary Supplement:
• Treatment vs control bread
Consumption of 200 grams per day of either treatment or control bread for eight weeks

Locations

Country	Name	City	State
Spain	Hospital Doctor Josep Trueta	Girona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)