Clinical trial · Interventional
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
A Pilot Study To Investigate the Biological Modulation of Familial Adenomatous Polyposis (FAP) by Lyophilized Black Raspberries
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Black Raspberry (BRB) Placebo Slurry | Drug | — | UNRESOLVED |
| Black raspberry (BRB) Slurry | Drug | — | UNRESOLVED |
| Black Raspberry (BRB) Suppositories | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Black Raspberry (BRB) Slurry plus BRB suppositories
- description
- 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
- interventionNames
- Drug: Black raspberry (BRB) Slurry
- Drug: Black Raspberry (BRB) Suppositories
- type
- EXPERIMENTAL
- label
- Black Raspberry (BRB) Placebo Slurry plus BRB suppositories
- description
- 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
- interventionNames
- Drug: Black Raspberry (BRB) Suppositories
- Drug: Black Raspberry (BRB) Placebo Slurry
Primary outcomes (2)
- measure
- Change From Baseline to End of Study in Number of Rectal Polyps
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy * Have an endoscopically assessable rectal segment * Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration. Exclusion Criteria: * Known allergies or hypersensitivity to berries * Diabetes mellitus * Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.
References
Publications (0)
Data not yet available