Ulcerative ColitisUCDNCT02922881
Microbiota-targeted Diet for Pediatric UC
A study testing Ulcerative Colitis Diet (UCD) in people with Ulcerative Colitis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ulcerative Colitis Diet (UCD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 30 Sep 2021
- 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 8 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Established diagnosis of UC
- Age: 8-19 (inclusive)
- Mild to moderate active disease, 10<PUCAI<45
- Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
- Participant has agreed to follow the UCD for 12 weeks
Who cannot join
- Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks
- Antibiotic or corticosteroid use in the past 2 weeks
- Use of biologics in present or in the past
- PUCAI>45
- Acute severe UC in the previous 12 months
- Current extra intestinal manifestation of UC
Show all 9Show fewer
- Primary Sclerosing Cholangitis (PSC) or liver disease
- Pregnancy
- Known food allergy to mandatory foods in the UCD
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.
- Conditions
- Ulcerative Colitis
- Being tested
- Ulcerative Colitis Diet (UCD)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulcerative Colitis Diet (UCD)Other
The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis Diet | Experimental | Participants will receive a structured 12-week diet with a step down phase. Receives: Other: Ulcerative Colitis Diet (UCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Measured: At 6 weeks following enrollment
Secondary outcomes (5)
Dietary Compliance
Using modified Medication Adherence Rating Scale (MARS) questionnaire
Measured: Up to 12 weeks following enrollment
Change in C-reactive protein (CRP) between baseline and week 12
Measured: 12 weeks
Change in erythrocyte sedimentation rate (ESR) between baseline and week 12
Measured: 12 weeks
Change in fecal calprotectin (FCP) between baseline and week 12
Measured: 12 weeks
Microbial composition of the gastrointestinal tract
Change in the microbial composition of the stool and rectum from baseline to 12 weeks.
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 posted4 Oct 2016 (estimated)
- Study start8 Mar 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Wolfson Medical Center, IWK Health Centre, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lindsey Albenberg, DO, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922881
- Sponsor's protocol ID
- 16-013075
- Acronym
- UCD
- Status last verified
- Dec 2021
- First submitted
- 13 Jun 2016
- Last updated
- 22 Dec 2021
- 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 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02922881
- Acronym / sponsor ID
- UCD / 16-013075
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Wolfson Medical Center, IWK Health Centre, National Institutes of Health (NIH)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis Diet | Experimental | Other: Ulcerative Colitis Diet (UCD)Participants will receive a structured 12-week diet with a step down phase. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Informed consent
- Established diagnosis of UC
- Age: 8-19 (inclusive)
- Mild to moderate active disease, 10<PUCAI<45
- Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
Key exclusion criteria (9 listed)
- Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks
- Antibiotic or corticosteroid use in the past 2 weeks
- Use of biologics in present or in the past
- PUCAI>45
- Acute severe UC in the previous 12 months
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 |
|---|---|---|
| Ulcerative Colitis Diet (UCD)The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission | Other | Ulcerative Colitis Diet |
Primary outcome
Clinical Remission
Time frame: At 6 weeks following enrollment
Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI)
5 secondary outcomes
Dietary Compliance
Time frame: Up to 12 weeks following enrollment
Change in C-reactive protein (CRP) between baseline and week 12
Time frame: 12 weeks
Change in erythrocyte sedimentation rate (ESR) between baseline and week 12
Time frame: 12 weeks
Change in fecal calprotectin (FCP) between baseline and week 12
Time frame: 12 weeks
Microbial composition of the gastrointestinal tract
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Lindsey Albenberg, DO principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulcerative Colitis Diet (UCD) in people with Ulcerative Colitis, run by Children's Hospital of Philadelphia at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 22 Dec 2021. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Remission (time frame: At 6 weeks following enrollment). 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 22 Dec 2021.