Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An open label pilot study
The purpose of this research study is to help us understand whether a diet can help children with Ulcerative Colitis (UC) to feel better without needing to take additional medications. Currently, it is thought that UC causes an imbalance in the good and bad bacteria that live inside our gut. We also know that certain foods can change how these good and bad bacteria live, and possibly contribute to UC symptoms. We think a specific diet could help create a better balance in your gut and help you feel better. This study is trying to figure out if a diet can help treat UC.
- Established diagnosis of Ulcerative Colitis
- Age 8-19
- Mild to moderate active disease
- Agreement to follow the UC Diet
- Stable medication use (5-ASA or Immunomodulator), or no medication use for the past 6 weeks (Participants who have received topical 5-ASA therapy for less than 7 days and have mild to moderate active disease may be eligible if topical therapy is stopped at enrollment.)
- No present or past use of a biologic medication, a class of medications including infliximab (Remicade) and adalimumab (Humira).
Study procedures will take place either at the Children's Hospital of Philadelphia or over the phone. Procedures are as follows:
- Screening visit, or prior to starting diet: Informational session about the diet, 24 hour dietary recall, stool collection, rectal swab collection, urine test, blood test, physical exam, interview
- Week 2: Telephone interview, compliance questions
- Week 3: Telephone interview, stool collection (to be mailed), 3-day food diary collection, compliance questions
- Week 6: 24 hour dietary recall, stool collection, rectal swab collection, compliance questions, urine test, blood test, physical exam, informational session about stage 2 of diet
- Week 12: Stool collection, blood test, physical exam
- Week 24: Telephone Interview
- Ulcerative Colitis Flare: Telephone interview - 24 hour dietary recall
Description of Treatment or Intervention (Mechanism of Action)
- This research study is an open label single arm pilot study involving treatment of children with active mild to moderate Ulcerative Colitis using a new diet.
- Participants will follow an exclusion diet for 3 months that consists of 2, 6 week phases- the first 6 weeks stricter than the second 6 weeks. The diet is low in dairy, animal fats, gluten and processed foods. Some allowed foods are certain fresh fruits and vegetables, chicken, yogurt, eggs, rice, pasta and certain oils. The portions of foods are carefully explained in the diet.
- In addition, stool samples, urine samples, rectal swabs, food logs, and questionnaires will be collected. We may also ask you to provide blood samples if they are not being ordered by your physician. There will be 3 study visits (including your enrollment visit) and up to 4 telephone calls.
Patient Participation Requirements
Active participation following the study diet for 3 months, and a follow-up phone call at 6 months.
Possible Risks & Side Effects
Participation in this study should not increase your risk for a flare. Any decision to increase your medications will be made by your regular GI doctor.
Risks of Study Diet:
- The diet we are studying restricts many common foods. We will ask you to report to us exactly what you are eating and drinking and in what quantities so that we can make sure that your intake is safe and healthy.
Risks of Blood Draw:
- Taking blood may cause some pain, bleeding or bruising at the spot where the needle enters your body. Rarely, taking blood may cause fainting or infection.
Risks of Stool & Urine Collection:
- Any stool or urine sample may contain germs that spread disease. It is important to carefully wash your hands and use careful handling techniques to avoid spreading infection. Some people may feel uncomfortable or embarrassed using the stool collection kit.
Risks of Swab Collection:
- Obtaining a rectal swab may feel uncomfortable.
Risks of Data Collection:
- There are no physical risks associated with answering questions, but you might experience momentary embarrassment or discomfort. You do not have to answer any questions that make you uncomfortable.
Risk of Breach of Privacy and Confidentiality:
- As with any study involving collection of data, there is the possibility of breach of confidentiality of data. Every precaution will be taken to secure participants' personal information to ensure confidentiality.