An interventional study of Osmolite 1.5 and Promote without fiber in Tube Feeding, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by University of Utah · Not applicable, Interventional, and Supportive care
Among 249 studies in Diarrhea with a site in United States — 15 open to participants now, 20 under way, none of them phase 3. Diarrhea · United States.
Among the 249 studies in Diarrhea with a site in United States, this one is the 115th largest by enrollment of the 223 interventional ones that give a count, is one of 13 that started in 2018, is one of 56 with no phase, and was the 181st registered.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
Browse Diarrhea studies →15 of the 249 studies in Diarrhea with a site in United States are open now. Recruiting first, the newest first:
Virginia Polytechnic Institute and State University · Sites in United States
Ages 6 mo+ · Healthy volunteers
Maryam Lustberg · Sites in United States
Ages 18+ · Healthy volunteers
Eli Lilly and Company · Sites in United States, Belgium, Canada and 7 more countries
Ages 18–75
Bausch Health Americas, Inc. · Sites in United States
Ages 6–12
Peach Perfect · Sites in United States
Ages 18–60
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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249 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 80 · Phase 3 43 · Phase 4 24
First in 1996; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Median enrollment 63 across the 223 interventional studies, 190 across the 16 observational. Of the 213 that completed or were terminated, 95 (45%) have results posted.
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99 of 249 have an industry lead sponsor. The 10 most frequent:
University of Utah is the lead sponsor of 996 studies on the registry; 177 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
University of Utah has 3 studies filed under Diarrhea — fewer than ten, so there is no comparison to draw.
10 of the studies in Diarrhea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01822470Indiana UniversitySmall Intestinal Bacterial Overgrowth: A Prospective Registry | 2026-12 |
| NCT05465629ViomeViome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions | 2026-12 |
| NCT06684470Mayo ClinicNovel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator | 2026-12-19 |
| NCT06801067Memorial Sloan Kettering Cancer CenterA Study of SER-155 to Treat Diarrhea in People on Immunotherapy | 2027-01-24 |
| NCT04826991Temple UniversityWells and Enteric Disease Transmission | 2027-03-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 249 studies in Diarrhea with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lower osmolality enteral tube feed formulation
Other: Promote without fiber
Higher osmolality enteral tube feed formulation
Other: Osmolite 1.5
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
Incidence of diarrhea at 72 hours
Time frame: 72 hour
Incidence of diarrhea at 14 days
Time frame: 14 days
Mean frequency of diarrhea days
Time frame: 14 days
Total number of diarrhea days
Time frame: 14 days
Mean diarrhea scores
Hart and Dobb Diarrhea Scale (a tool based on consistency and size of each stool, with a sum of all stools in one day equaling the score for each day and a score of 12 or more indicates diarrhea)
Time frame: 14 days
Time at 75% or more of goal tube feeding rate
Time frame: 14 days
Incidence of hypokalemia
Time frame: 14 days
Incidence of perineal dermatitis
Time frame: 14 days
Number of Clostridium difficile assays sent
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Jun 2019, 11 months.
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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