Colostrum and Gut Health

NCT07856979 | Not Yet Recruiting

• 1 other identifier: BOV 001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate changes in participant-reported gastrointestinal function over a 16-week intervention period and a 4-week non-supplementation period (20 weeks total) following daily consumption of two different doses of colostrum in comparison to a placebo. Secondary objectives include evaluation of digestive comfort, immune resilience, energy levels, sleep quality, hsCRP, metabolic panel, microbiome status and function, and hair and skin health. Exploratory objectives include the collection of physical activity status and pulse rate variability at specified timepoints to provide supportive contextual information alongside participant-reported outcomes.

Conditions

Gastrointestinal Health

Keywords

Bovine Colostrum; Colostrum; Gastrointestinal Health; Gut Health; Digestive Health; Gut Microbiome; Immune Resilience; Sleep; Energy; Dietary Supplement; Skin health; Hair health

Outcome Measures

Primary Outcomes (1)

• Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form

  Gastrointestinal function will be assessed using the PROMIS Gastrointestinal Combined Short Form (PROMIS-GI-SF), a self-administered questionnaire assessing dimensions of gastrointestinal status and function. The primary endpoint is the change in gastrointestinal function from baseline to the end of the 16-week supplementation period.

  Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20

Secondary Outcomes (30)

• Change in Digestive Comfort and Gut Health

  Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20

• Change in Perceived Immune System Strength and Resilience

  Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20

• Change in Participant-Reported Energy Levels

  Week 0, Week 2, Week 4, Week 8, Week 12, Week 16

• Change in Participant-Reported Sleep Quality

  Week 0, Week 2, Week 4, Week 8, Week 12, Week 16

• Change in total cholesterol

  Week 0 and Week 16

Other Outcomes (2)

• Daily Step Count

  Baseline through Week 20.

• Change in Wearable-Derived Heart Rate Variability

  Baseline through Week 20

Study Arms (3)

Lower Dose Bovine Colostrum

EXPERIMENTAL

Participants randomized to this group will consume the protocol-defined lower dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Dietary Supplement: Bovine Colostrum - Lower Dose

Higher-Dose Bovine Colostrum

EXPERIMENTAL

Participants randomized to this group will consume the protocol-defined higher dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Dietary Supplement: Bovine Colostrum - Higher Dose

Placebo

PLACEBO COMPARATOR

Participants randomized to this group will consume a matched placebo once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Dietary Supplement: Placebo

Interventions

Bovine Colostrum - Lower Dose DIETARY_SUPPLEMENT

Participants randomized to this group will consume the protocol-defined lower dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Lower Dose Bovine Colostrum

Bovine Colostrum - Higher Dose DIETARY_SUPPLEMENT

Participants randomized to this group will consume the protocol-defined higher dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Higher-Dose Bovine Colostrum

Placebo DIETARY_SUPPLEMENT

Participants randomized to this group will consume a matched placebo once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 30 to 60 years at the time of enrollment.
• Self-reported suboptimal digestive function (e.g., bloating, irregular bowel habits, discomfort) and/or suboptimal immune function (e.g., frequent colds, low energy) during the previous 4 weeks.
• Willing and able to consume a powdered supplement (3-6 g) mixed in liquid once daily.
• Own a compatible iOS or Android smartphone with internet access.
• Willing to connect a compatible wearable device (Apple Watch or Oura Ring) or Apple Health/Google Fit data source for passive data collection.
• Complete at least 30 minutes of physical activity or exercise most days of the week.
• Able to provide informed consent and comply with the study protocol for 20 weeks.
• Able to read and understand English.
• Willing to provide informed consent electronically.

You may not qualify if:

• Diagnosis of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other malabsorptive gastrointestinal disease or condition.
• Diagnosis of celiac disease or known severe allergy to dairy-derived or bovine colostrum products.
• Currently pregnant, breastfeeding, or planning pregnancy during the study period.
• Current or within the previous 30 days use of immunosuppressive medications, systemic corticosteroids, or biologic agents.
• Use of bovine colostrum or colostrum-containing supplements within the previous 30 days.
• Regular use of probiotic or prebiotic supplements within 14 days of enrollment. Does not participate in at least 30 minutes of physical activity or exercise most days of the week.
• Major gastrointestinal surgery within the previous 12 months.
• Autoimmune condition requiring immunomodulatory treatment.
• Participation in another interventional clinical study within 30 days of enrollment.
• Body mass index greater than 35.0 kg/m².
• Known or severe lactose intolerance or milk protein allergy.

Sponsors & Collaborators

• Bovita Labs, LLC: lead

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

Location

Central Study Contacts

Chad Kerksick, PhD

CONTACT

650-206-8006; chad.kerksick@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomized to receive one of two doses of bovine colostrum or a matched placebo. The study is described in the protocol as double-blind. Blinding and randomization will be facilitated through the Alethios platform.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel groups

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 5, 2026
• Study Start: September 4, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)