Dietary Interventions for Systemic Sclerosis
(DIGEST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how different diets, collectively known as the Systemic Sclerosis Diet, can alleviate bloating, abdominal pain, and other gut issues in individuals with systemic sclerosis (a condition that causes hardening and tightening of the skin and connective tissues). Participants will follow one of three diets: reducing fermentable carbs, avoiding foods harmful to gut health, or focusing on regular meals with fiber and portion control. This trial suits those already diagnosed with systemic sclerosis who experience moderate to severe bloating or distension. As an unphased trial, it offers an opportunity to explore dietary approaches that could enhance the quality of life for those with systemic sclerosis.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not have used systemic antibiotics within 4 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that dietary changes can affect symptoms in people with systemic sclerosis, a condition impacting the skin and internal organs. For Diet 1, which limits certain carbohydrates, studies suggest that individuals with similar conditions may experience worsened gut issues with high-fiber foods. This indicates the diet might help, but reactions vary.
Diet 2 involves eliminating foods that might harm the gut. While some research shows that certain diets don't significantly change symptoms in systemic sclerosis, removing specific foods could still be safe and beneficial for some individuals.
Diet 3 promotes regular meal times, eating soluble fiber, and controlling portion sizes. Research highlights the importance of good nutrition in managing systemic sclerosis, suggesting that structured eating may improve health without major safety concerns.
Overall, these diets appear well-tolerated, with no major safety issues reported in past studies. However, individual experiences can vary, so monitoring the body's response is important.12345Why are researchers excited about this trial?
Researchers are excited about these dietary interventions for systemic sclerosis because they offer a novel approach that focuses on nutrition rather than medication. Unlike standard treatments, which often include immunosuppressive drugs and physical therapy, these diets aim to improve health by modifying what people eat. The first diet restricts fermentable carbohydrates, which may reduce gut inflammation. The second eliminates foods harmful to the gut barrier and microbiome, potentially improving gut health and systemic inflammation. The third diet emphasizes regular meal patterns, soluble fiber, and portion control, aiming to stabilize gut function and improve overall wellness. These dietary approaches could provide a complementary or alternative option to traditional treatments, possibly with fewer side effects.
What evidence suggests that this trial's dietary interventions could be effective for Systemic Sclerosis?
This trial will compare three dietary interventions for managing stomach issues in people with systemic sclerosis, a condition affecting connective tissues. Diet 1 involves restricting fermentable carbohydrates. Studies suggest that reducing certain carbs, like those in a low-FODMAP diet, can alleviate bloating and stomach pain for some people, although other research found no significant symptom changes with this diet. Diet 2 focuses on eliminating foods harmful to the gut barrier and microbiome. A high-fiber, plant-based diet has been linked to better gut health and reduced inflammation. Diet 3 involves regular meal patterns, soluble fiber, and portion control, which can help with symptoms like bloating. Eating small, frequent meals with soluble fiber might also provide relief. Each diet offers potential benefits, but individual results can vary.12367
Who Is on the Research Team?
Dinesh Khanna, MD, MSc
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for individuals with Systemic Sclerosis experiencing gastrointestinal symptoms. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to be included.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to one of three diets to evaluate the effect on gastrointestinal symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Systemic Sclerosis Diet
Trial Overview
The study compares the effects of three different diets on gastrointestinal symptoms in Systemic Sclerosis patients: one eliminates harmful foods, another restricts fermentable carbs, and a third focuses on regular meals with soluble fiber.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Citations
Systemic Sclerosis DIet for GastrointESTinal Symptoms
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal symptom ...
Nutritional Status and Dietary Challenges in Patients ... - PMC
Nutritional impairments associated with SSc have significant clinical consequences. Malnutrition, sarcopenia, and frailty are linked to reduced muscle strength ...
Systemic Sclerosis DIet for GastrointESTinal Symptoms
This research will evaluate the effect of diets on bloating/distention, assess changes in abdominal pain, and overall gastrointestinal ...
Low FODMAP Diet: Evidence, Doubts, and Hopes
There was greater overall satisfaction and less bloating and abdominal pain in 86% of patients who carried out the LFD, compared to 49% of those who followed ...
Understanding the Gastrointestinal Microbiome in Systemic ...
In patients with SSc, the low-FODMAP diet did not influence significant differences in clinical symptoms or changes to the GI microbiome in a small cross- ...
Reduced fibre-fermenting capacity of gut microbes in multiple ...
Some people with multiple sclerosis display altered gut microbiota, with separate evidence suggesting high-fibre diet worsens symptoms. If gut ...
The Relationship Between Microbiota, Nutrition, and ...
GI symptoms are common in SSc patients (80% [60]) and although they are rarely the direct cause of death, they have an important impact on quality of life, ...
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