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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment bread | Active Comparator | Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques |
|
| Control bread | Placebo Comparator | Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment vs control bread | Dietary Supplement | Consumption of 200 grams per day of either treatment or control bread for eight weeks |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Aldeguer | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Doctor Josep Trueta | Girona | Catalonia | 17007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38363772 | Derived | Lluansi A, Lliros M, Carreras-Torres R, Bahi A, Capdevila M, Feliu A, Vila-Quintana L, Elias-Masiques N, Cueva E, Peries L, Torrealba L, Miquel-Cusachs JO, Sabat M, Busquets D, Lopez C, Delgado-Aros S, Garcia-Gil LJ, Elias I, Aldeguer X. Impact of bread diet on intestinal dysbiosis and irritable bowel syndrome symptoms in quiescent ulcerative colitis: A pilot study. PLoS One. 2024 Feb 16;19(2):e0297836. doi: 10.1371/journal.pone.0297836. eCollection 2024. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2019 | Dec 1, 2022 | Prot_SAP_000.pdf |
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