A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

Constipation Clinical Trial

Official title:

A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122571
• Other study ID #: 20351
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Trace Minerals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study. Be generally healthy - must not live with any uncontrolled disease.

Exclusion Criteria:

• Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders. Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.

Related Conditions & MeSH terms

• Bloating
• Constipation
• Gut Health

Intervention

Other:
• ConcenTrace
The product contains concentrated seawater from Utah's inland sea.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Trace Minerals	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]	The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.	12 weeks
Secondary	Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]	The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Type 1 has spent the longest time in the bowel and type 7 the least time.	12 weeks
Secondary	Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]	The frequency that the participants have a bowel movement will be recorded via questionnaires.	12 weeks