Nutritional programs to improve gastrointestinal health

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Gastrointestinal Conditions

This study is testing whether a special diet and supplements can help people with gastrointestinal issues feel better over four months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 25 Years to 75 Years
• Sex: All
• Sponsor: Viome (industry)
• Locations: 1 site (Bothell, Washington)
• Trial ID: NCT05465629 on ClinicalTrials.gov

What this trial studies

This study involves US residents with gastrointestinal issues who will be screened and enrolled after signing informed consent. Participants will complete a survey and be randomized into one of three groups: a control group, a group receiving Viome's condition-based supplements, or a group following the Viome Precision Nutrition Program. The interventions aim to provide dietary recommendations and supplements to alleviate symptoms associated with gastrointestinal wellness over a period of approximately four months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25-75 diagnosed with IBS according to ROME IV criteria and experiencing specific gastrointestinal symptoms.

Not a fit: Patients with conditions such as IBD, significant recent lifestyle changes, or those unwilling to modify their diet may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of gastrointestinal conditions through personalized nutrition and supplementation.

How similar studies have performed: While there is ongoing interest in personalized nutrition for gastrointestinal health, this specific approach using Viome's programs is relatively novel.

Eligibility criteria

Inclusion Criteria

* Resident of the United States
* Females and males ages 25-75 (inclusive)
* Able to speak and read English
* No unexplained weight loss, fevers, anemia, or blood in stool
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.
* Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (inclusive)

Exclusion criteria

* Unwilling to change current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* Women who are pregnant (current or planned in the next 4 months), or breastfeeding
* \< 90 days postpartum
* Active infection
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Significant diet or lifestyle changes in the previous 1 month
* IBD diagnosis
* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
* Cancer therapy within the previous 1 year
* Major surgery in the last 6 months or planned in the next 4 months
* Prescribed any drug(s) that may interact with the supplement formulations
* Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements
* Allergies to any study-specific supplement ingredients
* Currently on a specific diet:

FODMAP KETO PALEO

\- Gastrointestinal disease including: Esophagitis Celiac disease GI malignancy or obstruction Peptic ulcer Duodenal or gastric ulcer disease

* GI surgery except:

Appendectomy and benign polypectomy

Where this trial is running

Bothell, Washington

• Viome Life Sciences — Bothell, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Momchilo Vuyisich — Viome
• Study coordinator: Mory Mehrtash

Conditions: Gastrointestinal Health, Nausea, Vomiting, Diarrhea, Constipation, Bloating, Gastroesophageal, Viome