Systemic Sclerosis (SSc)DIGESTNCT07402226
Systemic Sclerosis DIet for GastrointESTinal Symptoms
A study testing Diet 1: Restriction of fermentable carbohydrates and Diet 2: Elimination of foods harmful to gut barrier and microbiome in people with Systemic Sclerosis (SSc), run by University of Michigan at 1 site in United States.
Trial summary
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Diet 1: Restriction of fermentable carbohydrates and Diet 2: Elimination of foods harmful to gut barrier and microbiome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria
- .• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.
- Willingness and ability to comply with dietary intervention and study procedures.
- Ability to provide informed consent.
Who cannot join
- Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.
- Use of systemic antibiotics within 4 weeks prior to baseline.
- History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).
- Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.
- Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.
- Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).
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- Clinically significant self-reported (≥10 percent weight loss) in the last 3 months
- BMI less than 20
- Ongoing tube feeds or TPN
- Participating in another interventional trial
- Pregnancy or lactation, or planning pregnancy in the next 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Rosemary Gedert, 734-764-6466, ssc-digest@med.umich.edu
Dinesh Khanna, MD, MSc
About this study
Official title: SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.
Read the detailed description
The rationale for keeping the diets (arms/interventions names) vague is it prevents other researchers from using these diets in their studies, minimizes expectation bias of patients (who can have preference for one diet over other) and prevents participants from trying other diets before end of study period in case they don't respond.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Diet 1: Restriction of fermentable carbohydrates, Diet 2: Elimination of foods harmful to gut barrier and microbiome, Diet 3: Regular meal patterns, soluble fiber, and portion control
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet 1: Restriction of fermentable carbohydratesBehavioural
6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms.
Diet 2: Elimination of foods harmful to gut barrier and microbiomeBehavioural
6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome
Diet 3: Regular meal patterns, soluble fiber, and portion controlBehavioural
6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.
| Study group | Role | What they receive |
|---|---|---|
| Diet 1: Restriction of fermentable carbohydrates | Experimental | Not described Receives: Behavioral: Diet 1: Restriction of fermentable carbohydrates |
| Diet 2: Elimination of foods harmful to gut barrier and microbiome | Experimental | Not described Receives: Behavioral: Diet 2: Elimination of foods harmful to gut barrier and microbiome |
| Diet 3: Regular meal patterns, soluble fiber, and portion control | Experimental | Not described Receives: Behavioral: Diet 3: Regular meal patterns, soluble fiber, and portion control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bloating severity
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.
Measured: Baseline to week 6
Secondary outcomes (3)
Change in Bloating severity
As assessed by the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0). The bloating score is a subsection of 4 questions with 4 options each. The score ranges from .0-3 where higher numbers indicate more frequent bloating.
Measured: Baseline to week 6
Change in Abdominal pain severity
As assessed by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a - 5 questions with raw summed score range of 6-25.
Measured: Baseline to week 6
Change in Overall GI symptom
UCLA SCTC GIT 2.0 total score (all sections but constipation) with a range of (0-2.83). Higher scores indicate more severe symtoms.
Measured: Baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start16 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Khanna, MD, MS, University of Michigan
- Investigators
- Dinesh Khanna, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402226
- Sponsor's protocol ID
- HUM00285136
- Acronym
- DIGEST
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2026
- Last updated
- 1 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07402226
- Acronym / sponsor ID
- DIGEST / HUM00285136
- Conditions
- Systemic Sclerosis (SSc)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Feb 2026 (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.
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.
Detailed description
The rationale for keeping the diets (arms/interventions names) vague is it prevents other researchers from using these diets in their studies, minimizes expectation bias of patients (who can have preference for one diet over other) and prevents participants from trying other diets before end of study period in case they don't respond.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet 1: Restriction of fermentable carbohydrates | Experimental | Behavioral: Diet 1: Restriction of fermentable carbohydrates |
| Diet 2: Elimination of foods harmful to gut barrier and microbiome | Experimental | Behavioral: Diet 2: Elimination of foods harmful to gut barrier and microbiome |
| Diet 3: Regular meal patterns, soluble fiber, and portion control | Experimental | Behavioral: Diet 3: Regular meal patterns, soluble fiber, and portion control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria
- .• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.
- Willingness and ability to comply with dietary intervention and study procedures.
- Ability to provide informed consent.
Key exclusion criteria (11 listed)
- Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.
- Use of systemic antibiotics within 4 weeks prior to baseline.
- History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).
- Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.
- Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.
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 |
|---|---|---|
| Diet 1: Restriction of fermentable carbohydrates6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms. | Behavioural | Diet 1: Restriction of fermentable carbohydrates |
| Diet 2: Elimination of foods harmful to gut barrier and microbiome6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome | Behavioural | Diet 2: Elimination of foods harmful to gut barrier and microbiome |
| Diet 3: Regular meal patterns, soluble fiber, and portion control6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control. | Behavioural | Diet 3: Regular meal patterns, soluble fiber, and portion control |
Primary outcome
Change in Bloating severity
Time frame: Baseline to week 6
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.
3 secondary outcomes
Change in Bloating severity
Time frame: Baseline to week 6
Change in Abdominal pain severity
Time frame: Baseline to week 6
Change in Overall GI symptom
Time frame: Baseline to week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- 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.
Dinesh Khanna, MD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet 1: Restriction of fermentable carbohydrates and Diet 2: Elimination of foods harmful to gut barrier and microbiome in people with Systemic Sclerosis (SSc), run by University of Michigan 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosemary Gedert (734-764-6466, ssc-digest@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bloating severity (time frame: Baseline to week 6). 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 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.