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NCT06628869
The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults
NA trial testing Fructanase in Digestive Health in 30 participants. Completed in 17 December 2024.
16 December 2024
Quick facts
| Lead sponsor | BIO-CAT, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 4 November 2024 |
| Primary completion | 16 December 2024 |
| Estimated completion | 17 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fructanase
- Maltodextrin placebo
Conditions studied
- Digestive Health — all drugs for Digestive Health →
- Gastrointestinal Health — all drugs for Gastrointestinal Health →
- FODMAP Intolerance — all drugs for FODMAP Intolerance →
- Food Sensitivity — all drugs for Food Sensitivity →
Sponsor
BIO-CAT, Inc.
Who can join
Adults 20 to 50, any sex, with Digestive Health or Gastrointestinal Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The carbohydrate inulin (from chicory root) is a healthy prebiotic ingredient found in dietary supplements and fortified foods (Nagy et al). Inulin is representative of a broader class of typically health-associated, yet fermentable carbohydrates called fructans that occur naturally in many vegetables, fruits, and wheat. Fructans, or long chains of fructose units, are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes. This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal (GI) symptoms like abdominal bloating, cramping, stomach rumbling, and flatulence (Bonnema et al; Briet et al; Bruhwyler et al), especially in individuals with irritable bowel syndrome (Van den Houte et al). A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion simulations (Guice et al) and a first-in-human safety trial (Garvey et al) helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin (25 grams). Secondary outcomes include breath hydrogen and methane levels, which serve as biomarkers of intestinal microbial fermentation. The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption, as well as lower breath biomarkers of intestinal microbial fermentation, compared to placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06628869
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Digestive Health
Currently open trials in the same condition.
- NCT07421596 — An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System · NA · recruiting
- NCT07271316 — Alii Supplement Study · Phase 2 · recruiting
- NCT06946017 — Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints · NA · recruiting
Other BIO-CAT, Inc. trials
Trials by the same sponsor.
- NCT05957185 — Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite · NA · completed
- NCT05744700 — Safety and Tolerability Trial of Microbial Inulinase · NA · completed
- NCT05295134 — Effect of Candida Rugosa Lipase on Serum Triglyceride Lowering · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06628869 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BIO-CAT, Inc.
- Last refreshed: 10 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06628869.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing