Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet 1: Restriction of fermentable carbohydrates | Experimental |
| |
| Diet 2: Elimination of foods harmful to gut barrier and microbiome | Experimental |
| |
| Diet 3: Regular meal patterns, soluble fiber, and portion control | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet 1: Restriction of fermentable carbohydrates | Behavioral | 6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 6 |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosemary Gedert | Contact | 734-764-6466 | ssc-digest@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dinesh Khanna, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
Not provided
Not provided
Not provided
Not provided
Not provided
Due to the dietary counseling intervention, it will not be possible to blind dietitians and participants. Participants will be aware of general participation in dietary therapy but blinded to specific diet names. Investigators, outcome assessors, and the biostatistician will be fully blinded to allocation.
| Diet 2: Elimination of foods harmful to gut barrier and microbiome | Behavioral | 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 control | Behavioral | 6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control. |
|
| 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. |
| 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. | Baseline to week 6 |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |