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| ID | Type | Description | Link |
|---|---|---|---|
| NL79442.091.22 | Other Identifier | METC Oost Nederlands |
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| Name | Class |
|---|---|
| Winclove Probiotics B.V. | INDUSTRY |
| China Scholarship Council | UNKNOWN |
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A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.
Rationale: Ulcerative colitis (UC) patients respond differently to treatments/interventions (e.g. diet/fecal microbiota transplantation), but the reason for this individual specificity remains unknown. The investigators hypothesize that the baseline fecal microbiota composition determines the efficacy of a treatment/intervention, and potential responders, i.e. patients showing symptoms improvement after treatment, can be predicted based on fecal microbiota composition.
Objective: The primary objective is to validate the prediction that prebiotics intervention boosts butyrate production and thereby induces a higher response (lower mean Patient Simple Clinical Colitis Activity Index (P-SCCAI) score) in mild UC patients with low intestinal Bacteroidetes levels (predicted responders), but not in those with high intestinal Bacteroidetes levels (predicted non-responders) at T = 8 weeks. The secondary objectives are to study the effects of prebiotics intervention on disease activity over time (T = 0, 4, 8, 12 and 60 weeks), mucosal inflammation, gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, quality of life, number of participants with increased or decreased medication use, and incidence of adverse events in mild UC patients.
Study design: This study is a four-arm double-blind randomized placebo-controlled parallel trial. It consists of a screening stage in which mild UC patients will be assigned to be predicted responders or predicted non-responders based on fecal Bacteroidetes levels. Afterwards the predicted responders and non-responders will be assigned to either the prebiotics group (arm 1 and 3) or placebo group (arm 2 and 4).
Study population: Adult subjects aged 18-65 years and body mass index 18-30 kg/m2 with mild UC defined by P-SCCAI (3-5 points in a 19-point scale), with at least one relapse in the last two years.
Intervention: An 8-week intervention period with four parallel arms: 1) predicted responders with prebiotics treatment (acacia gum, partially hydrolyzed guar gum, and resistant starch), 2) predicted responders with placebo (maltodextrin and corn starch), 3) predicted non-responders with prebiotics treatment, 4) predicted non-responders with placebo, during which the study participants consume the respective supplement (3 grams, twice daily).
Main study parameters/endpoints: The main parameter is the response (mean P-SCCAI score) between arms at T = 8 weeks. The secondary parameters are the disease activity over time at T = 0, 4, 8, 12, and 60 weeks, mucosal inflammation (fecal calprotectin), gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, health-related quality of life, number of participants with increased or decreased medication use, and incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicted responders with prebiotics | Experimental | Predicted responders, which are defined as UC patients having a relative abundance of Bacteroidetes <=10% in their feces, will receive 6 grams of prebiotics per day. |
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| Predicted responders with placebo | Placebo Comparator | Predicted responders, which are defined as UC patients having a relative abundance of Bacteroidetes <=10% in their feces, will receive 6 grams of placebo per day. |
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| Predicted non-responders with prebiotics | Experimental | Predicted non-responders, which are defined as UC patients having a relative abundance of Bacteroidetes >=15% in their feces, will receive 6 grams of prebiotics per day. |
|
| Predicted non-responders with placebo | Placebo Comparator | Predicted non-responders, which are defined as UC patients having a relative abundance of Bacteroidetes >=15% in their feces, will receive 6 grams of placebo per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotics | Dietary Supplement | The prebiotics consists of three non-digestible carbohydrates (40% acacia gum, 20% partially hydrolyzed guar gum, and 40% resistant starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Response between arms at T = 8 weeks | Within each arm, response will be determined by the mean Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). It refers to disease activity during the previous week, with higher scores representing worse disease symptoms. | Response at the end the intervention (T= 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity over time (T= 0, 4, 8, 12, and 60 weeks) | Disease activity will be determined by the Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). With P-SCCAI score <= 2 being regarded as clinical remission, and a decrease in the P-SCCAI score by more than two points from baseline being regarded as clinical response. Comparisons will be made between groups as well as within subjects over time. |
| Measure | Description | Time Frame |
|---|---|---|
| Habitual dietary intake | Habitual dietary intake including energy, nutrient, and fiber intake of the last month will be assessed by a validated food frequency questionnaire (FFQ) via FFQ-tool, a web-based interface tool. | FFQ will be taken at T= 0 (baseline). |
| Participants demographics and characteristics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erwin G Zoetendal, PhD | Contact | +31 (0)317- 483111 | erwin.zoetendal@wur.nl | |
| Zhuang Liu, MSc | Contact | +31 (0)617 659 164 | zhuang.liu@wur.nl |
| Name | Affiliation | Role |
|---|---|---|
| Erwin G Zoetendal, PhD | Laboratory of Microbiology, Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Gelderland | 6708WE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32889252 | Background | Liu Z, de Vries B, Gerritsen J, Smidt H, Zoetendal EG. Microbiome-based stratification to guide dietary interventions to improve human health. Nutr Res. 2020 Oct;82:1-10. doi: 10.1016/j.nutres.2020.07.004. Epub 2020 Jul 21. | |
| 33051190 | Background | Fassarella M, Blaak EE, Penders J, Nauta A, Smidt H, Zoetendal EG. Gut microbiome stability and resilience: elucidating the response to perturbations in order to modulate gut health. Gut. 2021 Mar;70(3):595-605. doi: 10.1136/gutjnl-2020-321747. Epub 2020 Oct 13. |
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As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2022 | Sep 9, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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A randomized, placebo-controlled, parallel, double-blind trial with two intervention arms and two control (placebo) arms.
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Neither the investigator, the participants, nor the outcome assessor will know who received what. No Care Provider is included in this trial.
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| Placebo | Dietary Supplement | The placebo consists of two digestible carbohydrates (20% maltodextrin and 80% corn starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening. |
|
| Disease activity during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks) |
| Mucosal inflammation | Mucosal inflammation will be determined by the fecal calprotectin level, which is a biomarker of inflammation and disease activity. | Change during and after the intervention (at T= 0, 8, 12, and 60 weeks) |
| GI complaints | The GI complaints will be assessed by the (gastrointestinal symptom rating scale) GSRS questionnaire, which has a seven-point graded scale where 1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms. | Change during the intervention (at T= 0, 4, and 8 weeks) |
| Stool consistency | Stool consistency will be measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea) on a daily basis for 7 days | Change during the intervention (at T= 0, 4, and 8 weeks) |
| Stool frequency | Stool frequency will be measured by counting number of defecation on a daily basis for 7 days. | Change during the intervention (at T= 0, 4, and 8 weeks)] |
| Fecal microbiota composition | Fecal microbiota composition will be determined by 16S rRNA gene sequencing. | Change during and after the intervention (at T= 0, 8, 12, and 60 weeks) |
| Fecal short-chain fatty acids concentrations | Fecal short-chain fatty acids concentrations will be determined by HPLC. | Change during and after the intervention (at T= 0, 8, 12, and 60 weeks) |
| Health-related quality of life | Health-related quality of life will be assessed by short inflammatory bowel disease questionnaire (SIBDQ) with a seven-point graded scale where 1 represents very troublesome symptoms and 7 represents the absence of troublesome symptoms. | Change during the intervention (at T= 0, 4, and 8 weeks) |
| Number of participants with increased or decreased medication use | It consists of the current medication use (e.g., aminosalicylates, corticosteroids, immunosuppressive agents, antimicrobial agents, and inhibitors of tumour necrosis factor-alpha (TNF- α)) with a downgrade meaning improvement and an upgrade meaning worsening of UC. | Change during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks) |
| Incidence of adverse events | Incidence of adverse events will be monitored by patient record and diary, these include all relapse-relevant information, including the need for systemic steroids, hospitalization, and surgery. | Change during the intervention (at T= 0, 4, and 8 weeks) |
General information (e.g., sex, age, BMI, disease duration, age at diagnosis, smoking habit, UC location, type of treatment) will be collected |
| This information will be collected at T= 0 (baseline). |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |