Ulcerative Colitis in Remission
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTreatment vs control bread
Consumption of 200 grams per day of either treatment or control bread for eight weeks
Sponsors
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed