Gastrointestinal HealthNCT07856979
Colostrum and Gut Health
A study testing Bovine Colostrum - Lower Dose and Bovine Colostrum - Higher Dose in people with Gastrointestinal Health, run by Bovita Labs, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health
- What is being tested?
- Bovine Colostrum - Lower Dose and Bovine Colostrum - Higher Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alethios, Inc.
San Francisco, California, 94109
Zeenia Framroze, MA, 650-206-8006, zeenia@alethios.com
Zoe Benham, BS, 650-206-8006, zoe@alethios.com
About this study
Official title: A Randomized Controlled Trial to Examine the Impact of Two Colostrum Doses on Gut Health
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.
Read the detailed description
This randomized, double-blind, placebo-controlled, fully decentralized study will evaluate the effects of two daily doses of bovine colostrum compared with placebo on gastrointestinal health and related health outcomes in adults. Aadults aged 30 to 60 years will be enrolled and randomized in a 1:1:1 ratio to one of three study groups: one of two bovine colostrum doses or a matched placebo. The study is designed to obtain approximately 105 participants who complete the protocol.
The study will be conducted entirely remotely, with no required in-person study visits. Following electronic screening and informed consent, eligible participants will complete baseline assessments through the Alethios digital research platform. Participants will then consume their assigned study product once daily with food for 16 weeks. The supplementation period will be followed by a 4-week non-supplementation period to evaluate outcomes following discontinuation of the study product. Total participant involvement is expected to be approximately 20 to 21 weeks.
The primary objective is to evaluate changes in participant-reported gastrointestinal function during the 16-week supplementation period. Gastrointestinal function will be assessed using the PROMIS Gastrointestinal (GI) Combined Short Form, with the primary endpoint defined as the change from baseline to Week 16.
Secondary outcomes will evaluate digestive comfort and gut health, perceived immune system strength and resilience, energy levels, sleep quality, metabolic health, gut microbiome status and function, and hair and skin health. Exploratory outcomes will include physical activity and heart rate variability derived from compatible wearable devices or connected health-data sources.
Participant-reported assessments will be completed at scheduled intervals throughout the study, including baseline and Weeks 2, 4, 8, 12, 16, and/or 20, depending on the specific outcome. Digestive comfort/gut health and immune resilience assessments will continue through the 4-week post-supplementation period to characterize changes following discontinuation of the study product.
Participants will also complete at-home biospecimen collections. Dried blood spot samples will be collected to assess metabolic health, including high-sensitivity C-reactive protein (hsCRP), and stool samples will be collected for assessment of gut microbiome status and function. These biospecimens will be collected at baseline and Week 16 and returned to designated analytical laboratories using provided collection and shipping materials. Participants will additionally provide standardized photographs for assessment of hair and skin health.
Study product adherence will be monitored electronically through the study platform. Participants will record study product intake during the supplementation period and will be able to report adverse events or other health concerns throughout the study. Where available, compatible wearable devices or connected Apple Health/Google Fit data sources will be used to passively collect physical activity and heart rate variability data.
The primary analysis will compare longitudinal changes in gastrointestinal function among the three randomized groups. A linear mixed-effects model will be used with supplementation group and time as fixed effects and participant as a random effect. Secondary and exploratory outcomes will be analyzed using statistical methods appropriate to the distribution and longitudinal structure of each outcome.
The study is intended to characterize the effects of daily bovine colostrum supplementation on gastrointestinal function and related consumer health outcomes and to explore whether changes in gastrointestinal health are accompanied by changes in digestive comfort, immune resilience, energy, sleep, metabolic markers, gut microbiome characteristics, hair and skin health, physical activity, and heart rate variability.
- Conditions
- Gastrointestinal Health
- Being tested
- Bovine Colostrum - Lower Dose, Bovine Colostrum - Higher Dose, Placebo
- Keywords
- Bovine Colostrum, Colostrum, Gastrointestinal Health, Gut Health, Digestive Health, Gut Microbiome, Immune Resilience, Sleep, Energy, Dietary Supplement, Skin health, Hair health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Colostrum - Lower DoseDietary 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.
Bovine Colostrum - Higher DoseDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Secondary outcomes (30)
Change in Digestive Comfort and Gut Health
Participants will rate their digestive comfort and gut health by answering the question, "Overall, how would you rate for digestive health and gut comfort today?" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Perceived Immune System Strength and Resilience
Participants will rate their immune strength and resilience by answering the question, "How would you rate the overall strength and resilience of your immune system over the past 7 days?" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Participant-Reported Energy Levels
Participants will rate their energy levels by answering the question, "In the past 7 days, how would you rate your overall energy levels throughout the day?" Answers are provided on a Likert scale ranging from 1 (Very low energy) to 7 (Very high energy).
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in Participant-Reported Sleep Quality
Participants will rate their sleep quality by answering the question, "In the past 7 days, how would you rate the quality of your sleep overall?" Answers are provided on a Likert scale ranging from 1 (Very poor sleep) to 7 (Excellent sleep).
Measured: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in total cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of total cholesterol. Units of measure are in milligrams per deciliter.
Measured: Week 0 and Week 16
Evaluation of baseline and change in microbial diversity
Participant-collected stool samples will be analyzed to evaluate changes in microbial diversity. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Measured: Week 0 and Week 16
Change in Hair Strength
Participants will rate their hair strength by answering the question, "My hair feels more nourished and less dry or brittle? Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Skin Hydration
Participants will rate their skin hydration by answering the question, "My skin feels hydrated?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in HDL cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of high-density lipoprotein (HDL) cholesterol. Units of measure are in milligrams per deciliter.
Measured: Week 0 and Week 16
Change in LDL cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of low-density lipoprotein (LDL) cholesterol. Units of measure are in milligrams per deciliter.
Measured: Week 0 and Week 16
Change in high-sensitivity C-reactive protein
At-home dried blood spot samples will be collected to evaluate concentrations of high-sensitivity C-reactive protein (CRP). Units of measure are in milligrams per liter.
Measured: Week 0 and Week 16
Change in hemoglobin A1c (HbA1c)
At-home dried blood spot samples will be collected to evaluate levels of hemoglobin A1c (HbA1c). Units of measure are in % of total hemoglobin.
Measured: Week 0 and Week 16
Change in gamma-glutamyl transferase (GGT)
At-home dried blood spot samples will be collected to evaluate concentrations of gamma-glutamyl transferase (GGT). Units of measure are in units per liter.
Measured: Week 0 and Week 16
Change in fasting glucose
At-home dried blood spot samples will be collected to evaluate fasting concentrations of glucose. Units of measure are in milligrams per deciliter.
Measured: Week 0 and Week 16
Evaluation of baseline and change in microbial abundance
Participant-collected stool samples will be analyzed to evaluate changes in microbial abundance. Evaluations are made based on detected bacterial taxa and strains. A percentage or proportion of relative abundance of total bacterial sequences will be quantified.
Measured: Week 0 and Week 16
Evaluation of baseline and change in microbial richness
Participant-collected stool samples will be analyzed to evaluate changes in microbial richness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Measured: Week 0 and Week 16
Evaluation of baseline and change in microbial evenness
Participant-collected stool samples will be analyzed to evaluate changes in microbial evenness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Measured: Week 0 and Week 16
Evaluation of baseline and change in the amount of short-chain fatty acid producers
Participant-collected stool samples will be analyzed to evaluate changes in bacterial taxa that are known fatty acid chain producers. General relative abunance (%) will be provided.
Measured: Week 0 and Week 16
Change in the ratio of triglycerides to HDL cholesterol ratio
At-home dried blood spot samples will be collected to evaluate changs in the ratio of triglycerides to HDL choelsterol. This measurement is a unitless ratio.
Measured: Week 0 and Week 16
Change in triglycerides
At-home dried blood spot samples will be collected to evaluate concentrations of triglycerides. Units of measure are in milligrams per deciliter.
Measured: Week 0 and Week 16
Modified hair pull test
Participants will complete a modified hair pull test. The number of hair strands yielded from the hair pull test will be counted and used for assessment.
Measured: Week 0 and Week 16
Change in Hair Quality
Participants will rate their hair quality by answering the question, "I have noticed an improvement in overall hair quality?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Hair Health
Participants will rate their hair health by answering the question, "I have noticed an improvement in the appearance of hair health?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Hair Texture
Participants will rate their hair texture by answering the question, "I have noticed an improvement in hair texture?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Hair Volume
Participants will rate their hair volume by answering the question, "I have noticed an improvement in hair volume?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Hair Shedding
Participants will rate their hair shedding by answering the question, "I have noticed an improvement in hair shedding?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Clearness of Skin
Participants will rate their skin clearness by answering the question, "My skin appears clear?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Overall Skin Health
Participants will rate their overall skin health by answering the question, "I have noticed an improvement in my overall skin health?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Dry Skin
Participants will rate their overall skin dryness by answering the question, "I am experiencing dry skin?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Change in Happiness with Skin
Participants will rate their overall happiness with their skin by answering the question, "I am happy with my skin?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Measured: Week 0 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start4 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bovita Labs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856979
- Sponsor's protocol ID
- BOV 001
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to participant privacy considerations, the inclusion of multiple potentially sensitive data types, and sponsor data-governance requirements. Aggregate study results may be disseminated through scientific publication and other appropriate channels.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Examine the Impact of Two Colostrum Doses on Gut Health
- ClinicalTrials.gov ID
- NCT07856979
- Acronym / sponsor ID
- BOV 001
- Conditions
- Gastrointestinal Health
- Keywords
- Bovine Colostrum, Colostrum, Gastrointestinal Health, Gut Health, Digestive Health, Gut Microbiome, Immune Resilience, Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Bovita Labs, LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double-blind, placebo-controlled, fully decentralized study will evaluate the effects of two daily doses of bovine colostrum compared with placebo on gastrointestinal health and related health outcomes in adults. Aadults aged 30 to 60 years will be enrolled and randomized in a 1:1:1 ratio to one of three study groups: one of two bovine colostrum doses or a matched placebo. The study is designed to obtain approximately 105 participants who complete the protocol.
The study will be conducted entirely remotely, with no required in-person study visits. Following electronic screening and informed consent, eligible participants will complete baseline assessments through the Alethios digital research platform. Participants will then consume their assigned study product once daily with food for 16 weeks. The supplementation period will be followed by a 4-week non-supplementation period to evaluate outcomes following discontinuation of the study product. Total participant involvement is expected to be approximately 20 to 21 weeks.
The primary objective is to evaluate changes in participant-reported gastrointestinal function during the 16-week supplementation period. Gastrointestinal function will be assessed using the PROMIS Gastrointestinal (GI) Combined Short Form, with the primary endpoint defined as the change from baseline to Week 16.
Secondary outcomes will evaluate digestive comfort and gut health, perceived immune system strength and resilience, energy levels, sleep quality, metabolic health, gut microbiome status and function, and hair and skin health. Exploratory outcomes will include physical activity and heart rate variability derived from compatible wearable devices or connected health-data sources.
Participant-reported assessments will be completed at scheduled intervals throughout the study, including baseline and Weeks 2, 4, 8, 12, 16, and/or 20, depending on the specific outcome. Digestive comfort/gut health and immune resilience assessments will continue through the 4-week post-supplementation period to characterize changes following discontinuation of the study product.
Participants will also complete at-home biospecimen collections. Dried blood spot samples will be collected to assess metabolic health, including high-sensitivity C-reactive protein (hsCRP), and stool samples will be collected for assessment of gut microbiome status and function. These biospecimens will be collected at baseline and Week 16 and returned to designated analytical laboratories using provided collection and shipping materials. Participants will additionally provide standardized photographs for assessment of hair and skin health.
Study product adherence will be monitored electronically through the study platform. Participants will record study product intake during the supplementation period and will be able to report adverse events or other health concerns throughout the study. Where available, compatible wearable devices or connected Apple Health/Google Fit data sources will be used to passively collect physical activity and heart rate variability data.
The primary analysis will compare longitudinal changes in gastrointestinal function among the three randomized groups. A linear mixed-effects model will be used with supplementation group and time as fixed effects and participant as a random effect. Secondary and exploratory outcomes will be analyzed using statistical methods appropriate to the distribution and longitudinal structure of each outcome.
The study is intended to characterize the effects of daily bovine colostrum supplementation on gastrointestinal function and related consumer health outcomes and to explore whether changes in gastrointestinal health are accompanied by changes in digestive comfort, immune resilience, energy, sleep, metabolic markers, gut microbiome characteristics, hair and skin health, physical activity, and heart rate variability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, parallel groups
| Arm | Type | Receives |
|---|---|---|
| Lower Dose Bovine Colostrum | Experimental | Dietary Supplement: Bovine Colostrum - Lower DoseParticipants 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. |
| Higher-Dose Bovine Colostrum | Experimental | Dietary Supplement: Bovine Colostrum - Higher DoseParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants randomized to this group will consume a matched placebo once daily with food for 16 weeks, followed by a 4-week non-supplementation period. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Colostrum - Lower DoseParticipants 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 | Lower Dose Bovine Colostrum |
| Bovine Colostrum - Higher DoseParticipants 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 | Higher-Dose Bovine Colostrum |
| PlaceboParticipants 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 |
Primary outcome
Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
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.
30 secondary outcomes
Change in Digestive Comfort and Gut Health
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Perceived Immune System Strength and Resilience
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Participant-Reported Energy Levels
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in Participant-Reported Sleep Quality
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in total cholesterol
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial diversity
Time frame: Week 0 and Week 16
Change in Hair Strength
Time frame: Week 0 and Week 16
Change in Skin Hydration
Time frame: Week 0 and Week 16
Change in HDL cholesterol
Time frame: Week 0 and Week 16
Change in LDL cholesterol
Time frame: Week 0 and Week 16
Change in high-sensitivity C-reactive protein
Time frame: Week 0 and Week 16
Change in hemoglobin A1c (HbA1c)
Time frame: Week 0 and Week 16
Change in gamma-glutamyl transferase (GGT)
Time frame: Week 0 and Week 16
Change in fasting glucose
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial abundance
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial richness
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial evenness
Time frame: Week 0 and Week 16
Evaluation of baseline and change in the amount of short-chain fatty acid producers
Time frame: Week 0 and Week 16
Change in the ratio of triglycerides to HDL cholesterol ratio
Time frame: Week 0 and Week 16
Change in triglycerides
Time frame: Week 0 and Week 16
Modified hair pull test
Time frame: Week 0 and Week 16
Change in Hair Quality
Time frame: Week 0 and Week 16
Change in Hair Health
Time frame: Week 0 and Week 16
Change in Hair Texture
Time frame: Week 0 and Week 16
Change in Hair Volume
Time frame: Week 0 and Week 16
Change in Hair Shedding
Time frame: Week 0 and Week 16
Change in Clearness of Skin
Time frame: Week 0 and Week 16
Change in Overall Skin Health
Time frame: Week 0 and Week 16
Change in Dry Skin
Time frame: Week 0 and Week 16
Change in Happiness with Skin
Time frame: Week 0 and Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to participant privacy considerations, the inclusion of multiple potentially sensitive data types, and sponsor data-governance requirements. Aggregate study results may be disseminated through scientific publication and other appropriate channels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine Colostrum - Lower Dose and Bovine Colostrum - Higher Dose in people with Gastrointestinal Health, run by Bovita Labs, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chad Kerksick, PhD (650-206-8006, chad.kerksick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form (time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.