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While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is uncertain whether delivery by enema distributes the FMT to the proximal segments of the colon. Positioning of the patient during the enema procedure may improve distribution to the proximal colon. Differences in distribution may explain the wide effect range and inferiority when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare the distribution of FMT from delivery by lower GI endoscopy versus enema with and without positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to project the distribution on colon X-ray pictures. To our knowledge this is not done in any previous study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast fluid by lower GI endoscopy and enema with and without positioning | Experimental | There is a washout period of at least four weeks between the two interventions (delivery by lower GI endoscopy and enema) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivery of contrast fluid by lower GI endoscopy | Other | Each participant will receive one delivery of 440 ml contrast fluid by lower GI endoscopy to the cecum of the colon. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. An colon X-ray is obtained within 10 minutes after the contrast fluid is delivered. The participants is in a supine position fram delivery and until the colon x-ray is obtained. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cecum projection after CF delivery by lower GI endoscopy versus enema with positioning versus enema without positioning of the participants. | Two radiologist determine the projection each colon X-ray picture by identifying segments where the gut mucosa is coated with contrast fluid and/or segments with contrast fluid in the lumen. The radiologist is blinded to which delivery method is used. | 10 minutes after contrast fluid delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of transverse colon projection after CF delivery by the lower GI endoscopy versus enema with positioning versus enema without positioning of the participants. | Two radiologist determine the projection each colon X-ray picture by identifying segments where the gut mucosa is coated with contrast fluid and/or segments with contrast fluid in the lumen. The radiologist is blinded to which delivery method is used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Johnsen, MD PhD | University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway, Harstad | Harstad | Troms | 9406 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37872499 | Derived | Skjevling LK, Hanssen HM, Valle PC, Goll R, Juul FE, Arlov O, Johnsen PH. Colonic distribution of FMT by different enema procedures compared to colonoscopy - proof of concept study using contrast fluid. BMC Gastroenterol. 2023 Oct 23;23(1):363. doi: 10.1186/s12876-023-02979-x. |
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Study protocol with statistical analysis plan will be uploaded to the ClinicalTrials.gov web site.
Within 2021
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|
| Delivery of contrast fluid by enema with and without positioning | Other | Each participant will receive one delivery of 440 ml contrast fluid by enema. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. The enema procedure includes:
|
|
| 10-20 minutes after contrast fluid delivery |
| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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