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

Conditions

• Gastrointestinal Disease Symptoms

Eligibility Criteria

Sex

FEMALE

Age

25 Years - 65 Years

Healthy Volunteers

Not accepted

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
• 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

Study Details

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.

Key Dates

Start date

May 1, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Treatment Group (probiotic supplement)
  This group will take a once daily supplement containing pre-pro-post biotics.
• Placebo Comparator: Control
  This group will be taking a once daily placebo pill.

Primary Outcome Measure

Short Chain Fatty Acid concentration in stool [ Time Frame: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks). ]

Central Contacts

• Dr. Tiffany Weir, PhD
  (970) 491-4631
  [email protected]
• Jenny Whittington, MS
  970-310-6843
  [email protected]

Locations (1)

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