Ulcerative ColitisINDUCTNCT03980405
Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis
A study testing Group 2- UCD Diet in people with Ulcerative Colitis, run by Prof. Arie Levine at 1 site in Israel.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Group 2- UCD Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Established diagnosis of UC by the Paris classification and Revised Porto Criteria.
- Age: 10 - 19 years (inclusive)
- Mild to moderate active disease, 10 ≤ PUCAI ≤45
- Extent E2-E4 by the Paris classification
- Weight >30 kg (ensures that patients who received 5ASA ≤2 grams are eligible)
- Stable medication (IMM/ 5ASA) use or no change in medication use for the past 6 weeks. Patients who have received topical 5ASA therapy for <10 days and are active may be included if topical therapy is stopped at enrolment.
- Patients not receiving 5ASA or using 5ASA<50mg/kg/day
Who cannot join
- Any proven current infection such as positive stool culture, parasite or C. difficile.
- Steroids (oral or intravenous) use in the past 3 months.
- Patients who continue topical 5ASA or steroids after enrolment
- Use of biologics in present or in past 6 months
- Use of antibiotics for more than one week in the past 60 days
- PUCAI >45
Show all 14Show fewer
- Acute severe UC in the previous 12 months.
- Current extra intestinal manifestation of UC.
- Primary Sclerosing Cholangitis (PSC) or Liver disease
- Pregnancy.
- Vegans or patients unwilling or unable to consume eggs
- Inflammatory Bowel Disease (IBD) unclassified
- Stool culture, parasite or C. difficile will only be measured if the patient has diarrhea.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
This will be a 12 week, single blinded Randomized controlled trial (RCT) in children and adolescents with mild to moderate Ulcerative Collitis (UC) comparing 5ASA (recommended dosing 60-75 mg/kg/day; minimum 2.5 maximum 4 grams/day) with fiber restriction for 6 weeks followed by free diet (Group 1) to 5ASA with Ulcerative Collitis Diet (UCD) for 6 weeks, followed by the step down UCD for the next 6 weeks. Inclusion criteria will include children weighing >30kg, Pediatric Ulcerative Collitis Activity index (PUCAI) 10-45, no treatment with 5ASA (treatment naïve or treated with thiopurines for example) or currently treatment with 5ASA but <2 grams/day, ages 10-19 years, with disease extent E2-E4 by the Paris Classification. Patients on thiopurines may continue existing dose if dose is stable for at least 8 weeks.
Exclusion criteria are Patients with acute severe colitis (ASC) in the previous year, requiring oral or intravenous steroids in the previous 3 months, or patients treated with Anti- Tumor necrosis factor alfa (TNFa) regimens. Importantly, there is no placebo arm and both groups will be treated with the same currently recommended drug at currently recommended doses; the only difference between groups being their diets.
The primary endpoint will be remission defined as PUCAI<10 at week 6; Secondary endpoints will be response defined as a drop in PUCAI of 10 or remission at week 6, sustained steroid free remission week 12 and improvement in mucosal healing by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at week 12 as well as safety and tolerance. Intolerance will be defined as patients stopping the diet because of refusal to continue diet. Patients will be seen at weeks 0, 3, 6, and 12. PUCAI will be assessed at every visit; fecal calprotectin will be assessed at baseline, week 6 and 12. Sigmoidoscopy to assess mucosal healing will be performed at week 12 in patients who had a baseline colonoscopy or sigmoidoscopy. Sigmoidoscopies to evaluate healing will be voluntary and patients will not be excluded if they do not consent to have a follow up sigmoidoscopy.
- Conditions
- Ulcerative Colitis
- Being tested
- Group 1- Control Diet, Group 2- UCD Diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1- Control DietDietary supplement
Oral 5ASA+ Low Residue Diet for 6 weeks and Oral 5ASA+ Free Diet for 6 more weeks
Group 2- UCD DietDietary supplement
Oral 5ASA+ UC Diet for 6 weeks and Oral 5ASA+ UC Diet Stage 2 for 6 more weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Control Diet 6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ Low residue diet and 6 more weeks of Oral 5ASA+ Free diet Receives: Dietary Supplement: Group 1- Control Diet |
| Group 2 | Experimental | 6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ UC diet and 6 more weeks of Oral 5ASA+ UC diet stage 2 Receives: Dietary Supplement: Group 2- UCD Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUCAI< 10 at week 6
Remission defined as PUCAI<10 at week 6
Measured: 6 weeks
Secondary outcomes (6)
A drop of PUCAI at least 10 points or remission
Response defined as a drop of PUCAI at least 10 points or remission (intention to treat) week 6 .
Measured: 6 weeks
Mean/median change in Calprotectin at week 6
Mean/median change in Calprotectin at week 6
Measured: 6 weeks
Sustained remission week 12
Sustained steroid \& biologic free remission week 12
Measured: 12 weeks
Need for topical therapy by week 12
Need for topical therapy by week 12
Measured: 12 weeks
Change in UCEIS at week 12 ( optional)
Change in UCEIS at week 12 ( optional)
Measured: 12 weeks
Tolerance to diet
Tolerance to diet defined by withdrawal from the study because of difficulties with the diet.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Apr 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Why it stopped: It is not possible to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Arie Levine
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Arie Levine, Wolfson Medical Center
- Investigators
- Arie Levine, Prof, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980405
- Sponsor's protocol ID
- 0001-19-WOMC
- Acronym
- INDUCT
- Status last verified
- May 2022
- First submitted
- 5 Jun 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03980405
- Acronym / sponsor ID
- INDUCT / 0001-19-WOMC
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is not possible to continue the study
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prof. Arie LevineOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This will be a 12 week, single blinded Randomized controlled trial (RCT) in children and adolescents with mild to moderate Ulcerative Collitis (UC) comparing 5ASA (recommended dosing 60-75 mg/kg/day; minimum 2.5 maximum 4 grams/day) with fiber restriction for 6 weeks followed by free diet (Group 1) to 5ASA with Ulcerative Collitis Diet (UCD) for 6 weeks, followed by the step down UCD for the next 6 weeks. Inclusion criteria will include children weighing >30kg, Pediatric Ulcerative Collitis Activity index (PUCAI) 10-45, no treatment with 5ASA (treatment naïve or treated with thiopurines for example) or currently treatment with 5ASA but <2 grams/day, ages 10-19 years, with disease extent E2-E4 by the Paris Classification. Patients on thiopurines may continue existing dose if dose is stable for at least 8 weeks.
Exclusion criteria are Patients with acute severe colitis (ASC) in the previous year, requiring oral or intravenous steroids in the previous 3 months, or patients treated with Anti- Tumor necrosis factor alfa (TNFa) regimens. Importantly, there is no placebo arm and both groups will be treated with the same currently recommended drug at currently recommended doses; the only difference between groups being their diets.
The primary endpoint will be remission defined as PUCAI<10 at week 6; Secondary endpoints will be response defined as a drop in PUCAI of 10 or remission at week 6, sustained steroid free remission week 12 and improvement in mucosal healing by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at week 12 as well as safety and tolerance. Intolerance will be defined as patients stopping the diet because of refusal to continue diet. Patients will be seen at weeks 0, 3, 6, and 12. PUCAI will be assessed at every visit; fecal calprotectin will be assessed at baseline, week 6 and 12. Sigmoidoscopy to assess mucosal healing will be performed at week 12 in patients who had a baseline colonoscopy or sigmoidoscopy. Sigmoidoscopies to evaluate healing will be voluntary and patients will not be excluded if they do not consent to have a follow up sigmoidoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Group 1- Control DietControl Diet 6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ Low residue diet and 6 more weeks of Oral 5ASA+ Free diet |
| Group 2 | Experimental | Dietary Supplement: Group 2- UCD Diet6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ UC diet and 6 more weeks of Oral 5ASA+ UC diet stage 2 |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Informed consent
- Established diagnosis of UC by the Paris classification and Revised Porto Criteria.
- Age: 10 - 19 years (inclusive)
- Mild to moderate active disease, 10 ≤ PUCAI ≤45
- Extent E2-E4 by the Paris classification
Key exclusion criteria (14 listed)
- Any proven current infection such as positive stool culture, parasite or C. difficile.
- Steroids (oral or intravenous) use in the past 3 months.
- Patients who continue topical 5ASA or steroids after enrolment
- Use of biologics in present or in past 6 months
- Use of antibiotics for more than one week in the past 60 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1- Control DietOral 5ASA+ Low Residue Diet for 6 weeks and Oral 5ASA+ Free Diet for 6 more weeks | Dietary supplement | Group 1 |
| Group 2- UCD DietOral 5ASA+ UC Diet for 6 weeks and Oral 5ASA+ UC Diet Stage 2 for 6 more weeks | Dietary supplement | Group 2 |
Primary outcome
PUCAI< 10 at week 6
Time frame: 6 weeks
Remission defined as PUCAI<10 at week 6
6 secondary outcomes
A drop of PUCAI at least 10 points or remission
Time frame: 6 weeks
Mean/median change in Calprotectin at week 6
Time frame: 6 weeks
Sustained remission week 12
Time frame: 12 weeks
Need for topical therapy by week 12
Time frame: 12 weeks
Change in UCEIS at week 12 ( optional)
Time frame: 12 weeks
Tolerance to diet
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: It is not possible to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Levine, Prof principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2- UCD Diet in people with Ulcerative Colitis, run by Prof. Arie Levine at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It is not possible to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PUCAI< 10 at week 6 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.