Antibiotic Associated DiarrheaPhase 1/2NCT01941160
Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment
A Phase 1/2 study testing Lacidofil® STRONG in people with Antibiotic Associated Diarrhea, run by KGK Science Inc. at 1 site in Canada.
Trial summary
The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Associated Diarrhea
- What is being tested?
- Lacidofil® STRONG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Apr 2014
- Phase
- Phase 1/2
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 50 years inclusive
- Body mass index 18.0 - 29.9 kg/m2
- Healthy as determined by laboratory results, medical history and physical exam
- Agrees to comply with study procedures
- Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics) and activity/training levels during the course of the study
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Body mass index ≥ 30 kg/m2
- Average number of formed bowel movements > 3 per day or < 3 per week
- Participation in a clinical research trial within 30 days prior to randomization
- Use of antibiotics within 60 days prior to randomization.
- Habitual use of pro- and/or prebiotic products. Subjects must not consume foods or supplements containing added pro- and/or prebiotics within 3 weeks prior to randomization and during the course of the study
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- Use of laxatives, enemas or suppositories 1 week prior to randomization and for the duration of the study
- Follows a vegetarian or vegan diet
- Unstable medical conditions, as determined by the Qualified Investigator
- History of chronic gastrointestinal disorders including irritable bowel syndrome; chronic constipation; chronic diarrhea; dyspepsia; gastroesophageal reflux disease; diverticulitis; colitis; Crohn's disease; or any other malabsorption or gastrointestinal disorder
- Subjects with an immuno-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
- Alcohol use > 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
- Allergy or sensitivity to test product ingredients or Amoxicillin/Clavulanic Acid
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of a Probiotic Product, Lacidofil® STRONG, in Healthy Adults Taking Antibiotic Treatment
The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.
Read the detailed description
It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.
- Conditions
- Antibiotic Associated Diarrhea
- Being tested
- Lacidofil® STRONG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidofil® STRONGDietary supplement
Lacidofil® STRONG capsule twice daily
PlaceboDietary supplement
Placebo capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin/Clavulanic Acid and Lacidofil® STRONG | Experimental | Participants are provided in double blinded fashion Lacidofil® STRONG to take with antibiotics Receives: Dietary Supplement: Lacidofil® STRONG |
| Placebo | Placebo comparator | Participants are provided in double blinded fashion placebo to take with antibiotics Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes are the between group difference in mean Bristol Stool Scores (consistency) and the between group difference in the mean number of bowel movements (frequency).
Measured: Up to 63 days
Secondary outcomes (2)
Incidence of AAD
Proportion of subjects having diarrhea-like defecation defined as a stool frequency ≥ 3 per a 24 h period and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days (48 h period)
Measured: Up to 63 days
Influence of Lacidofil® STRONG on side effects associated with antibiotic use
Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects
Measured: Up to 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Associated DiarrheaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Dale Wilson, MD, KGK Science Inc.
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941160
- Sponsor's protocol ID
- 13LAHL
- Status last verified
- Mar 2014
- First submitted
- 23 Aug 2013
- Last updated
- 14 May 2014
- Results posted
- No