Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women

NCT06834984 | Recruiting

• 1 other identifier: 6393
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. The primary outcome will be to assess gastrointestinal health using bowel movement tracking, self-report and objective assessments of gastrointestinal symptom severity, stool levels of short chain fatty acids, changes in the gut microbiota, including recovery of LGG and BB-12, and functional measures of the microbiome. Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress, anxiety, sleep, and quality of life.

Conditions

Gastrointestinal Disease Symptoms

Keywords

Women with gastrointestinal symptoms; Probiotic; Prebiotic

Outcome Measures

Primary Outcomes (6)

• Short Chain Fatty Acid concentration in stool

  Gas chromatography will be used to measure changes in SCFA production in stool.

  4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).

• Fecal pH

  Stool sample pH will be measured before and after treatment.

  4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).

• Fermentation Rate of microbiome

  This is a functional measure of the microbiome and will be measured ex-vivo Radio Frequency Identification (RFID) system. Stool sample microbes will be assessed for fermentation rates.

  4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).

• Microbial composition (alpha and beta diversity, dysbiosis index, differential taxa)

  Changes in microbiota profiles, ratio of pro-inflammatory to beneficial microbes, recovery of LGG \& BB-12 in stool; measured using 16s rRNA and targeted assays.

  2X: baseline, and final (12 weeks)

• Total number and types of bowel movements

  Defecation frequency and proportion of abnormal to normal bowel movements as recorded in a diary using the Bristol Stool Form Scale. The scale runs from 1-7 with healthier outcomes associated with 3-5 on the Bristol scale.

  Daily for 12 weeks

• Gastrointestinal Symptom Rating Scale

  Measures Abdominal Pain Heartburn Acid Regurgitation Sucking Sensations in the Epigastrium Nausea \& Vomiting Borborygmus (rumbling) Abdominal Distension (bloating) Eructation (burping) Flatus (gas) Decreased or Increased Passage of Stools Loose or Hard Stools Urgent Need for Defecation Feeling of Incomplete Evacuation Rated on a scale starting at "No Discomfort at all" to "Very severe discomfort", where better outcomes are associated with "No Discomfort At All" while worse outcomes are associated near(er) to "Very Severe Discomfort".

  4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).

Secondary Outcomes (25)

• Fecal calprotectin

  3X: baseline, mid-point (6 weeks), final (12 weeks)

• Alpha-1 antitrypsin

  3X: baseline, mid-point (6 weeks), final (12 weeks)

• Lipopolysaccharide binding protein and soluble CD14 in blood

  2X: baseline, and final (12 weeks)

• Human high sensitivity T-cell panel/Peripheral blood mononuclear cells (PBMCs)

  2X: baseline, and final (12 weeks)

• Alpha-1 antitrypsin in blood

  2X: baseline, and final (12 weeks)

Study Arms (2)

Treatment Group (probiotic supplement)

EXPERIMENTAL

This group will take a once daily supplement containing pre-pro-post biotics.

Dietary Supplement: Prebiotic, probiotic, postbiotic combination

Control

PLACEBO COMPARATOR

This group will be taking a once daily placebo pill.

Dietary Supplement: Placebo

Interventions

Prebiotic, probiotic, postbiotic combination DIETARY_SUPPLEMENT

The product consists of two probiotics, Lactobacillus rhamnosus LGG and Bifidibacterium animalis subsp. lactis BB-12, supplied at a total concentration of 11B CFU's, a prebiotic consisting of 1 × 106 Plaque Forming Units (PFU) LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae bacteriophages, marketed as PreforPro, and tributyrin- a stale form of butyrate

Treatment Group (probiotic supplement)

Placebo DIETARY_SUPPLEMENT

Placebo pill containing stomach acid-resistant outer vegan capsule (hypromellose, gellan gum), hi oleic safflower oil, inner vegan capsule (hypromellose, gellan gum) microcrystalline cellulose, ascorbyl palmitate, silica

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult women (age 25-65, with target average age of 50).
• BMI \<30.
• with moderate gastrointestinal symptoms.
• Participants should be willing to follow the study protocol and attend clinic visits.

You may not qualify if:

• less than 25 years of age or greater than 65 years of age.
• have a BMI \>30.
• taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment.
• Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
• pregnant and breastfeeding people.
• overuse of alcohol as determined on a case-by-case self-reported alcohol use.
• if the individual feels they are unable to adhere to the study requirements, which includes consuming capsules, providing stool or blood samples, tracking bowel movements and symptoms, and attending scheduled clinic visits.

Sponsors & Collaborators

• Colorado State University: lead
• Ritual: collaborator

Study Sites (1)

Colorado State University Food and Nutrition Clinical Research Laboratory

Fort Collins, Colorado, 80523, United States

RECRUITING

MeSH Terms

Interventions

Prebiotics; Probiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Central Study Contacts

Dr. Tiffany Weir, PhD

CONTACT

(970) 491-4631; tiffany.weir@colostate.edu

Jenny Whittington, MS

CONTACT

970-310-6843; ijwhitt@rams.colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Some of the sponsor staff will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 19, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)