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The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints.
The main questions this trail aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic intervention | Experimental | Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance. |
|
| Prebiotic intervention | Active Comparator | Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Participants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire. | Before and after eight weeks of intake of the dietary supplement. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition | Change in gut microbiome composition, assessed using a stool sample. | Before and after eight weeks of intake of the dietary supplement. |
| Inflammatory markers | Change in serum inflammatory markers, assessed by a blood sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Occurrence of side effects of the supplementation, assessed by questioning. | After the eight weeks of intake of the dietary supplement. |
Inclusion Criteria (at screening):
Exclusion Criteria (at screening):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Perret, Prof. Dr. | Contact | +41419396650 | claudio.perret@paraplegie.ch | |
| Anneke Hertig-Godeschalk, PhD | Contact | +41419396603 | anneke.hertig@paraplegie.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jivko Stoyanov, Prof. Dr. | Swiss Paraplegic Research, Nottwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Research | Recruiting | Nottwil | Canton of Lucerne | 6207 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41562992 | Derived | Trunz J, Schmandt C, Hertig-Godeschalk A, Glisic M, Stoyanov J, Perret C. Probiotic and Prebiotic Supplementation for Gastrointestinal Discomfort in Chronic Spinal Cord Injury (PRO-GIDSCI): A Randomized Controlled Crossover Trial Protocol. Methods Protoc. 2026 Jan 17;9(1):14. doi: 10.3390/mps9010014. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Open-label two-arm randomized controlled crossover trial
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| Prebiotic | Dietary Supplement | Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks. |
|
| Before and after eight weeks of intake of the dietary supplement. |
| Gastrointestinal transit time | Change in gastrointestinal transit time, assessed by the blue dye test (time from ingestion to first appearance of blue food dye in the stool). | Before and after eight weeks of intake of the dietary supplement. |
| D014947 | Wounds and Injuries |
| D019602 |
| Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |