Cranberry for Crohn's Disease

Overseen By Madeline Johns

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Ana Maldonado-Contreras

Must be taking: Thiopurines, Methotrexate, Anti-TNF, others

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Ostomy, Pregnancy, Stricture, others

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a cranberry-based supplement can improve gut health in people with Crohn's disease. Crohn’s disease often causes an imbalance in gut bacteria, and cranberry compounds might help restore this balance. Participants will take either a cranberry supplement or a placebo for 10 weeks and provide samples for researchers to study changes in gut bacteria and inflammation. This trial suits adults with Crohn's disease who experience a moderate to severe impact on daily life and can regularly consume the supplement. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial requires that your current medications be stable before starting. You don't need to stop them, but they should be at a stable dose for a certain period before the trial begins.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cranberry extract powder is generally safe when used in food. One study found it safe at the suggested amounts. Animal studies of colitis, a condition similar to Crohn's disease, have shown that cranberry products can help with inflammation.

Cranberry has long been used to reduce the risk of urinary tract infections, indicating it is well-tolerated. Although cranberry is not specifically approved for Crohn's disease, its use in other areas suggests it is safe. However, since this is an early phase trial, researchers are still learning about its safety for people with Crohn's disease. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Crohn's Disease, which often involve medications like corticosteroids or immune system suppressors, cranberry powder is a natural product that may offer a gentler alternative. Researchers are intrigued by cranberry's unique active compounds, such as proanthocyanidins, which are thought to have anti-inflammatory and antioxidant properties. These compounds might help reduce inflammation in the digestive tract without the side effects associated with conventional drugs. This novel approach could pave the way for a more holistic and less invasive treatment option for those with Crohn's Disease.

What evidence suggests that cranberry powder might be an effective treatment for Crohn's disease?

Research suggests that cranberry supplements might improve gut health in people with Crohn's disease. Some studies have shown that cranberry can reduce gut inflammation, a key factor in Crohn's disease. For example, one study found that cranberry extract reduced the severity of gut inflammation in mice. Another study discovered that short-term cranberry use increased the variety of beneficial gut bacteria. In this trial, participants in the intervention arm will receive cranberry whole powder to evaluate its potential in managing Crohn's disease symptoms by promoting a healthier gut environment. ^{1 3 6 7 8}

Who Is on the Research Team?

Ana Maldonado-Contreras, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

Adults aged 18-65 with Crohn's Disease, having low disease activity and moderate to severely impaired quality of life can join. They must be on stable medication doses, willing to consume cranberry supplements daily, comply with sample collection and study procedures, and provide consent. Women must use effective contraception.

Inclusion Criteria

I will use a highly effective form of birth control during the study.

I am willing and able to take a cranberry supplement every day.

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a cranberry supplement or placebo daily for 10 weeks

10 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cranberry powder

Trial Overview The trial is testing if a daily cranberry supplement improves gut health in Crohn's patients over 10 weeks versus a placebo. It measures the effects on gut bacteria balance, inflammation, and overall health through questionnaires and blood, urine, stool samples collected at four times during the study.

How Is the Trial Designed?

Group I: Cranberry Experimental Treatment 1 Intervention

Participants in the intervention arm will be provided with 7 servings of Cranberry whole powder per week. Participants in the intervention arm are expected to consume 1 serving per day of cranberry whole powder for 10 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants in the placebo arm will be provided with 7 servings of placebo powder (placebo supplement matched in appearance and flavor) per week. Participants in the placebo arm are expected to consume a serving per day of placebo powder for 10 weeks.

Who Is Running the Clinical Trial?

Ana Maldonado-Contreras

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07170462

Cranberry and Gut Health in Crohn's Disease This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6800821/

Dietary cranberry suppressed colonic inflammation and ... The results showed that dietary cranberry significantly decreased the severity of colitis in DSS-treated mice, evidenced by increased colon length, and ...

3. nature.com nature.com/articles/s41522-024-00493-w

Short term supplementation with cranberry extract ... The administration of cranberry extract for four days resulted in a significant increase in species richness (p ≤ 0.05) and a decrease in α- ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0308814614010292

Preventive effects of cranberry products on experimental ... Cranberry products prevent symptoms of DSS-induced colitis in mice. Cranberry phenolics and fibre reduce inflammatory responses in colitis.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11332073/

Anthocyanins-rich cranberry extract attenuates DSS-induced ... The supplementation of cranberry extract resulted in an alleviation of IBD symptoms, evidenced by improvements in the disease activity index ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7010106/

Safety of cranberry extract powder as a novel food ... The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels.

7. mdpi.com mdpi.com/2076-0817/10/9/1217

A Cranberry Concentrate Decreases Adhesion and ... This in vitro study evaluated the impact of a cranberry concentrate Type M (CTM) on adherent-invasive Escherichia coli (AIEC) LF82, a pathobiont associated ...

8. webmd.com webmd.com/drugs/2/drug-19572/cranberry-powder-oral/details

Cranberry Powder Oral: Uses, Side Effects, Interactions ... Cranberry has been used for reducing the risk of bladder infections (urinary tract infections). It has also been used for decreasing the smell of urine.