Inflammatory Bowel DiseasesPRODUCENCT03301311
Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
A study testing Specific Carbohydrate Diet (SCD) and Modified Specific Carbohydrate Diet (MSCD) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 20 sites in United States.
Trial summary
A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Specific Carbohydrate Diet (SCD) and Modified Specific Carbohydrate Diet (MSCD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 Apr 2018to 8 Sep 2020
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
- Age 7-18 years
- Enrolled in the ImproveCareNow (ICN2) registry
- Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.
- Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.
Who cannot join
- Complex and Unstable IBD:
- Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or ostomy
- Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
- Ever had history of full colectomy
- Hospitalization or surgery planned within 3 months
- Ongoing active gastrointestinal infection
Show all 24Show fewer
- Severe Malnutrition (BMI less than 5th percentile)
- Recent medication changes including:
- Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
- Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
- Vedolizumab started within 16 weeks prior to enrollment
- Increase in corticosteroids within 4 weeks of screening or have dose >20 mg prednisone or equivalent
- Evidence of Other Complicating Medical Issues:
- Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
- Serious psychological or psychiatric conditions such as eating disorders or self-harm
- Pregnancy
- Tobacco, alcohol, or illicit drug abuse
- Inability to Complete the Protocol
- Non-English speaking participants
- On SCD or modified SCD anytime within 8 weeks of enrollment
- If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
- Participants on a vegan diet
- Lack of smart phone and data plan for participating caregiver
- Participating in another concurrent intervention study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
GI Care for Kids
Atlanta, Georgia, 30342
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Massachusetts General Hospital
Boston, Massachusetts, 02114
Levine Children's Hospital
Charlotte, North Carolina, 28203
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Soutwestern Medical Center
Dallas, Texas, 75235
Pediatric Specialists of Virginia
Fairfax, Virginia, 22031
Riley Hospital for Children
Indianapolis, Indiana, 46202
Nemours Children's Speciality Care
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Nemours Children's Hospital
Orlando, Florida, 32827
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Oregon Health Sciences University
Portland, Oregon, 97239
University of California San Francisco Benioff Children's Hospita;
San Francisco, California, 94158
Seattle Children's
Seattle, Washington, 98105
Nemours, Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.
- Being tested
- Specific Carbohydrate Diet (SCD), Modified Specific Carbohydrate Diet (MSCD)
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Carbohydrate Diet (SCD)Other
Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
Modified Specific Carbohydrate Diet (MSCD)Other
Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
| Study group | Role | What they receive |
|---|---|---|
| Specific Carbohydrate Diet (First) | Experimental | Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey. Receives: Other: Specific Carbohydrate Diet (SCD); Other: Modified Specific Carbohydrate Diet (MSCD) |
| Modified Specific Carbohydrate Diet (First) | Experimental | Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted. Receives: Other: Specific Carbohydrate Diet (SCD); Other: Modified Specific Carbohydrate Diet (MSCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Self-reported number of stools per day entered as an integer in the study mobile app
Measured: Daily through study completion (34 weeks from randomization)
Stool Consistency
Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app
Measured: Daily through study completion (34 weeks from randomization)
Pain Interference
Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
Measured: Weekly through study completion (34 weeks from randomization)
Gastrointestinal Symptoms
Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
Measured: Weekly through study completion (34 weeks from randomization)
Fecal Calprotectin
Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.
Measured: At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times
Secondary outcomes (5)
Provider measured disease activity
Pediatric Ulcerative Colitis Index (PUCAI) or Short Pediatric Crohn's Index (sPCDAI) are completed by care providers at all scheduled clinic visits as part of standard of care and are entered into the ImproveCareNow (ICN) registry.
Measured: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Laboratory markers of disease activity and inflammation
C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), albumin, and hematocrit as collected as part of standard of care and are entered into the ImproveCareNow (ICN) registry.
Measured: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Growth
Weight and height are collected at all clinic visits and at the dietitian study follow up visits (2 weeks into the first diet period of each diet). These data are entered into the ICN registry as part of regular data entry. We will calculate weight for age Z-scores for all entries during study period. The age-specific mean and standard deviation from U.S. population norms will be used to calculate Z-scores using the Centers for Disease Control Epi-Info program.
Measured: At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Short Crohn's Disease Activity Index (sCDAI)
The short Crohn's disease activity index (sCDAI) will be used to assess disease activity based on self-report via the study app. For the sCDAI, items assess general well-being, abdominal pain, and liquid stools. Respondents are asked to report on symptoms for the previous 24 hour period. Scores are calculated based on a published algorithm.
Measured: Weekly through study completion (34 weeks from randomization)
Pediatric Ulcerative Colitis Activity Index (PUCAI)
A self-reported version of the Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to assess disease activity based on self-report via the study app. For the PUCAI, respondents are asked to report on abdominal pain, bloody stools, stool consistency, stool frequency, nocturnal stools, and activity level over the prior 24-hours. A weighted, summed score is calculated with higher scores indicating worse disease (score range 0-85).
Measured: Weekly through study completion (34 weeks from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start10 Apr 2018
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Seattle Children's Hospital, Dayton Children's Hospital, Brown University
- Responsible party
- Sponsor
- Investigators
- Heather C Kaplan, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiLisa Opipari-Arrigan, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301311
- Sponsor's protocol ID
- CIN001-PRODUCE
- Acronym
- PRODUCE
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2017
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to provide access to the de-identified, HIPAA-compliant databases as required within a year after the study has been completed. Data plans, analysis plans, data dictionaries, study manuals and annotated case report forms will be made available, upon request, in a read-only format (PDF). Each dataset will be accompanied by appropriate documentation listing each variable, variable definition, decode values (if appropriate), an indication of the variable as a source collected or derived variable, and derivation algorithms for any derived values. Datasets will be available as SAS, SAS transport, XML or CSV with labels. Other formats may be created if requested. All necessary security measures will be taken to ensure patient privacy and confidentiality, and details on how data may be used, including the use of de-identified data sets, will be included in the informed consent.
Publications
Kaplan HC, Opipari-Arrigan L, Yang J, Schmid CH, Schuler CL, Saeed SA, Braly KL, Chang F, Murphy L, Dodds CM, Nuding M, Liu H, Pilley S, Stone J, Woodward G, Yokois N, Goyal A, Lee D, Yeh AM, Lee P, Gold BD, Molle-Rios Z, Zwiener RJ, Ali S, Chavannes M, Linville T, Patel A, Ayers T, Bassett M, Boyle B, Palomo P, Verstraete S, Dorsey J, Kaplan JL, Steiner SJ, Nguyen K, Burgis J, Suskind DL; ImproveCareNow Pediatric IBD Learning Health System. Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials. Am J Gastroenterol. 2022 Jun 1;117(6):902-917. doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.
PubMed 35442220
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
- ClinicalTrials.gov ID
- NCT03301311
- Acronym / sponsor ID
- PRODUCE / CIN001-PRODUCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Seattle Children's Hospital, Dayton Children's Hospital, Brown University
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 4 Oct 2017 (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.
A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)
| Arm | Type | Receives |
|---|---|---|
| Specific Carbohydrate Diet (First) | Experimental | Other: Specific Carbohydrate Diet (SCD), Other: Modified Specific Carbohydrate Diet (MSCD)Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey. |
| Modified Specific Carbohydrate Diet (First) | Experimental | Other: Specific Carbohydrate Diet (SCD), Other: Modified Specific Carbohydrate Diet (MSCD)Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
- Age 7-18 years
- Enrolled in the ImproveCareNow (ICN2) registry
- Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.
Key exclusion criteria (24 listed)
- Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or ostomy
- Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
- Ever had history of full colectomy
- Hospitalization or surgery planned within 3 months
- Ongoing active gastrointestinal infection
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 |
|---|---|---|
| Specific Carbohydrate Diet (SCD)Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet. | Other | Modified Specific Carbohydrate Diet (First), Specific Carbohydrate Diet (First) |
| Modified Specific Carbohydrate Diet (MSCD)Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet. | Other | Modified Specific Carbohydrate Diet (First), Specific Carbohydrate Diet (First) |
Primary outcome
Stool frequency
Time frame: Daily through study completion (34 weeks from randomization)
Self-reported number of stools per day entered as an integer in the study mobile app
Stool Consistency
Time frame: Daily through study completion (34 weeks from randomization)
Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app
Pain Interference
Time frame: Weekly through study completion (34 weeks from randomization)
Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
Gastrointestinal Symptoms
Time frame: Weekly through study completion (34 weeks from randomization)
Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
Fecal Calprotectin
Time frame: At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times
Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.
5 secondary outcomes
Provider measured disease activity
Time frame: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Laboratory markers of disease activity and inflammation
Time frame: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Growth
Time frame: At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
Short Crohn's Disease Activity Index (sCDAI)
Time frame: Weekly through study completion (34 weeks from randomization)
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Time frame: Weekly through study completion (34 weeks from randomization)
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 28 Jun 2022.
- Results publication: PubMed 35442220Kaplan HC, Opipari-Arrigan L, Yang J, Schmid CH, Schuler CL, Saeed SA, Braly KL, Chang F, Murphy L, Dodds CM, Nuding M, Liu H, Pilley S, Stone J, Woodward G, Yokois N, Goyal A, Lee D, Yeh AM, Lee P, Gold BD, Molle-Rios Z, Zwiener RJ, Ali S, Chavannes M, Linville T, Patel A, Ayers T, Bassett M, Boyle B, Palomo P, Verstraete S, Dorsey J, Kaplan JL, Steiner SJ, Nguyen K, Burgis J, Suskind DL; ImproveCareNow Pediatric IBD Learning Health System. Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials. Am J Gastroenterol. 2022 Jun 1;117(6):902-917. doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.
- Individual participant dataSharing planned: Yes. We intend to provide access to the de-identified, HIPAA-compliant databases as required within a year after the study has been completed. Data plans, analysis plans, data dictionaries, study manuals and annotated case report forms will be made available, upon request, in a read-only format (PDF). Each dataset will be accompanied by appropriate documentation listing each variable, variable definition, decode values (if appropriate), an indication of the variable as a source collected or derived variable, and derivation algorithms for any derived values. Datasets will be available as SAS, SAS transport, XML or CSV with labels. Other formats may be created if requested. All necessary security measures will be taken to ensure patient privacy and confidentiality, and details on how data may be used, including the use of de-identified data sets, will be included in the informed consent.
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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.
Heather C Kaplan, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Lisa Opipari-Arrigan, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Carbohydrate Diet (SCD) and Modified Specific Carbohydrate Diet (MSCD) in people with Inflammatory Bowel Diseases and Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 20 sites 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 5 inclusion and 24 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 28 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 20 sites 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?
Stool frequency (time frame: Daily through study completion (34 weeks from randomization)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301311, which also lists 1 linked publication.
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 28 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.