A Phase 2 interventional study of Sucrase and Placebo in Short Gut Syndrome, sponsored by University of Miami. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by University of Miami · Phase 2, Interventional, and Treatment
Short gut syndrome with intestinal failure patients may have decreased production of disaccharidases, like sucrase, an enzyme responsible for digesting sugar in foods. This can happen due to loss of bowel length from surgery or from loss of cellular function in the intestines due to use of parenteral nutrition intravenously. Therefore, patients with these conditions may not be able to digest sucrose (sugar) fully. Patients might experience abdominal distension/pain, vomiting and diarrhea when sugar is taken in orally or through the g-tube, which can limit patients' ability to increase oral or g-tube feeds in short gut syndrome patients with intestinal failure.
In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 3 is below the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive sucrase for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of placebo.
Drug: Sucrase · Other: Placebo
Participants in this arm will receive placebo for 4 weeks followed by wash out of 1 week with no drug administered then 4 weeks of sucrase.
Drug: Sucrase · Other: Placebo
1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight. 2 mL (17,000 I.U.) for patients over 15kg in body weight. Dosage is 1 or 2 mL (8,500 to 17,000 I.U.) taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
1 mL of placebo per meal or snack for patients up to 15 kg in body weight. 2 mL of placebo per meal of snack for patients above 15kg in body weight. Dosage is 1 or 2 mL of placebo taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
Change in Carbohydrate Malabsorption
Degree of carbohydrate malabsorption will be assessed by decrease in number of stools per day.
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Patient Symptom Survey
Degree of carbohydrate malabsorption will be assessed by change in patient symptomatology by change in score on patient symptom survey. The survey has range from 0-52 with higher score being worse symptoms and lower being better.
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Growth Velocity
Carbohydrate malabsorption will be measured by increase in growth velocity in kg/week
Time frame: baseline, 9 weeks
Change in Carbohydrate Malabsorption as Measured by Enteral Nutrition Tolerance
Carbohydrate malabsorption will be measured by ability to advance enteral nutrition in ml/day
Time frame: baseline, 9 weeks
Change in Digestion
Change in digestion will be measured by change in abdominal distension/girth measured in cm
Time frame: baseline, 9 weeks
Change in Digestion as Measured by Amount of Emesis
Change in digestion will be assessed by number of emesis per day
Time frame: baseline, 9 weeks
Change in Digestion as Measured by Stool Consistency
Change in digestion will be assessed as a change in stool consistency from liquid (7) to solid(1) using Bristol stool chart
Time frame: baseline, 9 weeks
| Milestone | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
| Milestone | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention |
|---|---|---|
| Started | 2 | 1 |
| Completed | 1 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
Degree of carbohydrate malabsorption will be assessed by decrease in number of stools per day.
No measurements were reported for this outcome.
Degree of carbohydrate malabsorption will be assessed by change in patient symptomatology by change in score on patient symptom survey. The survey has range from 0-52 with higher score being worse symptoms and lower being better.
No measurements were reported for this outcome.
Carbohydrate malabsorption will be measured by increase in growth velocity in kg/week
No measurements were reported for this outcome.
Carbohydrate malabsorption will be measured by ability to advance enteral nutrition in ml/day
No measurements were reported for this outcome.
Change in digestion will be measured by change in abdominal distension/girth measured in cm
No measurements were reported for this outcome.
Change in digestion will be assessed by number of emesis per day
No measurements were reported for this outcome.
Change in digestion will be assessed as a change in stool consistency from liquid (7) to solid(1) using Bristol stool chart
No measurements were reported for this outcome.
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sucrase Intervention Followed by Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Placebo Followed by Sucrase Intervention | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention | Total |
|---|---|---|---|
| <=18 years | 2 | 1 | 3 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sucrase Intervention Followed by Placebo | Placebo Followed by Sucrase Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: No
Ran from Jan 2022 to primary completion in Sep 2024, 31 months.
Results were first posted in Oct 2025, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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