Ritual Synbiotic+ for Gastrointestinal Health in Women
This study is testing a dietary supplement called Ritual Synbiotic+, which contains prebiotics, probiotics (Lactobacillus rhamnosus LGG and Bifidibacterium animalis subsp. lactis BB-12), and postbiotics. It aims to see how this supplement affects digestive health, mood, and behavior in women. You may be able to join if you are a healthy woman between 25 and 65 years old, have a Body Mass Index (BMI) less than 30, and experience moderate gastrointestinal symptoms. The study will look at changes in your stool, including short chain fatty acid levels and pH, to see if the supplement is effective. The study is currently recruiting about 60 participants.
- Study design
- This is a double-blinded, randomized study, meaning neither you nor the researchers will know if you are receiving Ritual Synbiotic+ or a placebo. Around 60 women will participate.
- What's involved
- You will need to follow the study protocol and attend clinic visits. Stool samples will be collected at baseline, 3 days, 6 weeks, and 12 weeks.
- Compensation
- Participants will be compensated for their participation.
- Follow-up
- Your progress will be monitored for 12 weeks after starting the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women
At a glance
Conditions
NCT06834984
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Colorado State University Food and Nutrition Clinical Research Laboratory
Fort Collins, Coloradono site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Gastrointestinal Symptom Rating Scale4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
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".
- Total number and types of bowel movementsDaily for 12 weeks
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.
- Short Chain Fatty Acid concentration in stool4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Gas chromatography will be used to measure changes in SCFA production in stool.
- Fecal pH4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Stool sample pH will be measured before and after treatment.
- Microbial composition (alpha and beta diversity, dysbiosis index, differential taxa)2X: baseline, and final (12 weeks)
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.