Combination Therapy with Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative colitis: A Single Blinded, International Randomized Controlled Trial

Combination Therapy with Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative colitis: A Single Blinded, International Randomized Controlled Trial - INDUCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54904

Enrollment

Registered

2020-05-13

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bowel inflammation Inflammatory bowel disease

Interventions

Current clinical practice is to reduce exposure (now withhold fiber) to fiber during active bleeding and diarrhea and to gradually increase access to grains fruit and vegetables once patients improv

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent 2. Established diagnosis of UC by the Paris classification and Revised Porto Criteria. 3. Age: 10 - 19 years (inclusive) 4. Mild to moderate active disease, 10 30 kg (ensures that patients who received 5ASA

Exclusion criteria

Exclusion criteria: 1. Any proven current infection such as positive stool culture, parasite or C. difficile. 2. Steroids (oral or intravenous) use in the past 3 months. 3. Patients who continue topical 5ASA or steroids after enrolment 4. Use of biologics in present or in past 6 months 5. Use of antibiotics for more than one week in the past 60 days 6. PUCAI >45 7. Acute severe UC in the previous 12 months. 8. Current extra intestinal manifestation of UC. 9. PSC or Liver disease 10. Pregnancy. 11. Vegans or patients unwilling or unable to consume eggs 12. IBD unclassified Exclusion criteria Comments: 1. Stool culture, parasite or C. difficile will only be measured if the patient has diarrhea. 2. Patients who have received treatment enemas for 3 weeks or less then 3 days and are active, can be included but must stop the enemas on the day of enrolment

Design outcomes

Primary

Measure	Time frame
Remission defined as PUCAI	—

Secondary

Measure	Time frame
Clinical Secondary End Points: - Response defined as a drop of PUCAI at least 10 points or remission (intention to treat) week 6 . - Mean/median change in Calprotectin at week 6 - Sustained steroid & biologic free remission week 12 - Need for topical therapy by week 12 - Change in UCDEIS at week 12 ( optional) - Tolerance to diet defined by withdrawal from the study because of difficulties with the diet. Translational Secondary End Points: - Changes to the microbiome: diet vs. no diet - Change in microbiome: remission vs. failures - Short chain fatty acids in stool by group week 6	—

Measure

Time frame

Clinical Secondary End Points: - Response defined as a drop of PUCAI at least 10 points or remission (intention to treat) week 6 . - Mean/median change in Calprotectin at week 6 - Sustained steroid & biologic free remission week 12 - Need for topical therapy by week 12 - Change in UCDEIS at week 12 ( optional) - Tolerance to diet defined by withdrawal from the study because of difficulties with the diet. Translational Secondary End Points: - Changes to the microbiome: diet vs. no diet - Change in microbiome: remission vs. failures - Short chain fatty acids in stool by group week 6

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)