Back to resultsImpact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis
Primary Purpose
Ulcerative Colitis in Remission
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment vs control bread
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis in Remission
Eligibility Criteria
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
Sites / Locations
- Hospital Doctor Josep Trueta
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment bread
Control bread
Arm Description
Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques
Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05656391
First Posted
December 1, 2022
Last Updated
December 18, 2022
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
1. Study Identification
Unique Protocol Identification Number
NCT05656391
Brief Title
Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis
Official Title
Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis in Remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment bread
Arm Type
Active Comparator
Arm Description
Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques
Arm Title
Control bread
Arm Type
Placebo Comparator
Arm Description
Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment vs control bread
Intervention Description
Consumption of 200 grams per day of either treatment or control bread for eight weeks
Primary Outcome Measure Information:
Title
Changes in IBS-like symptomatology
Description
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 Outcome Measure Information:
Title
Changes in the abundance of bacterial markers
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Aldeguer
Organizational Affiliation
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Doctor Josep Trueta
City
Girona
State/Province
Catalonia
ZIP/Postal Code
17007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis
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