BridgeMD
New treatment option for Digestive Health
Official title Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
ClinicalTrials.gov ID: NCT06946017
What this study is testing
- What it's testing
- A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Aside from having participants fitting the inclusion and
You likely can't join if
- below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to...
- Healthy people living in the Phoenix area in AZ, USA during the study
- Women/Men aged between 18-50 years (50-50%)
- Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
- BMI value between ≥18.5 and ≤ 30 kg/m2
- No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
See the full eligibility criteria
- Aside from having participants fitting the inclusion and
- below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to the Part I (i.e. no self-reported GI tract issues (GSRS questionnaire...
- Healthy people living in the Phoenix area in AZ, USA during the study
- Women/Men aged between 18-50 years (50-50%)
- Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
- BMI value between ≥18.5 and ≤ 30 kg/m2
- No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
- Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.
- Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.
- Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).
- Written informed consent
- For part I: Self-perceived lactose intolerance, and/or omission of dairy products, and/or identifying as Hispanic/Latino or Asian
- For part I: Determined to be lactase non-persistent (LNP) CC genotype by qPCR, and/or positive lactose intolerance test (\>20ppm increase from baseline when 25g of lactose administered) Exclusion Criteria:
- Users of (sport) supplements containing probiotics and/or prebiotics and those unwilling to temporarily stop use of these supplements at least 3 weeks prior to start of the intervention
- Women who plan to start or stop the use of contraceptives before or during study period
- Women that have additional or worse GI symptoms during their period that can be classified as severe
- Smoking
- Clinical lactose intolerance
- Clinical or self-perceived milk protein allergy
- Diagnosed GI tract disorders or diseases
- Musculoskeletal disorders
- Diagnosed metabolic disorders (such as diabetes)
- Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- Chronic use of gastric acid suppressing medication or anti-coagulants
- Chronic use of anti-inflammatory medication
- Use of antibiotics the past 0-6 months
- Blood donation in the past 2 months
- (Intending to become) Pregnant/lactating women
- Significant changes in body weight during the past 4 weeks (i.e., due to reduction of body weight through limiting caloric intake, illness,)
- Athletes should not aim to lose bodyweight by reducing energy intake during the study
- For Part I: A hydrogen breath peak of less than 20 ppm over baseline during a lactose tolerance test
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.