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New treatment option for Crohn Disease (CD)
Official title Cranberry and Gut Health in Crohn's Disease
ClinicalTrials.gov ID: NCT07170462
What this study is testing
What is Cranberry powder?
Cranberry powder is an investigational medicine, given as an once-daily, being studied as a potential treatment for crohn disease (cd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adult CD patients between 18 and 65 years old.
- Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.
- Confirmed diagnosis of Crohn's disease.
- CD activity lower than sCDAI\<450.
- Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score \<60.
You likely can't join if
- Ostomy
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
- Pregnancy
- Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening
- Use of probiotics within 4 weeks of screening
- Use of antibiotics within 4 weeks of screening
See the full eligibility criteria
- Adult CD patients between 18 and 65 years old.
- Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.
- Confirmed diagnosis of Crohn's disease.
- CD activity lower than sCDAI\<450.
- Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score \<60.
- Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks),
- steroids (1 week).
- Willingness and capacity to significantly consume the cranberry supplement daily.
- Willing and able to comply with specimen collection and other study procedures, and to complete the study.
- Able to provide written informed consent.
- Reside in Massachusetts, USA.
- Ostomy
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
- Pregnancy
- Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening
- Use of probiotics within 4 weeks of screening
- Use of antibiotics within 4 weeks of screening
- \> 20mg prednisone or equivalent
- Recent C. difficile colitis
- Unable to provide informed consent for themselves
- Prisoners
- Children
The study team makes the final eligibility decision.
Where it's taking place
- Worcester, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Worcester, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.