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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01770808 |
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Date of registration:
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14/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort
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Scientific title:
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A Randomised, Double-blind, Placebo-controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Improves Digestive Discomfort in Healthy Subjects |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01770808 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Eamonn Quigley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College Cork |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must;
1. Be able to give written informed consent.
2. Be a female between 18 and 65 years of age.
3. Be a non-pregnant female.
4. Be in generally good health as determined by the investigator.
5. Have no evidence of gastrointestinal disease or of a functional gastrointestinal
disorder as determined by the Bowel Disease Questionnaire.
6. Experience occasional bloating and stomach discomfort, defined as 1-2 times/weeks,
but not greater that 2 times/week over the last 3 months.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
1. Are less than 18 and greater than 65 years of age.
2. Are pregnant females.
3. Are currently taking probiotics, vitamin supplements or plant sterols ester
supplements or have taken them in the past 14 days.
4. Have received a diagnosis or attending a doctor for Irritable Bowel Syndrome or a
functional bowel disorder.
5. Experience bloating, flatulence and stomach discomfort greater that 2 times/week,
over the last 3 months.
6. Have a significant acute or chronic coexisting illness (cardiovascular,
gastrointestinal, endocrinological, immunological, metabolic or any condition which
contraindicates, in the investigators judgement, entry to the study).
7. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or
recent unexplained bleeding.
8. Having a condition or taking a medication that the investigator believes would
interfere with the objectives of the study, pose a safety risk or confound the
interpretation of the study results; to include anti-inflammatory drugs,
corticosteroids, laxatives, enemas, antibiotics (within 1 month), probiotics,
anti-coagulants, vitamin supplements and over-the counter non-steroidal analgesics.
9. Be a smoker
10. Suffer from alcohol abuse.
11. Suffer from psychiatric disease.
12. Subjects are lactose intolerant or have dietary habits (slimming or vegetarian diet)
which could interfere with the assessment of the study product.
13. Individuals who, in the opinion of the investigator, are considered to be poor
attendees or unlikely for any reason to be able to comply with the trial.
14. Subjects may not be receiving treatment involving experimental drugs.
15. If the subject has been in a recent experimental trial, these must have been
completed not less than 30 days prior to this study.
16. Have a malignant disease or any concomitant end-stage organ disease
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Digestive System Disorders
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: AquaCal
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Dietary Supplement: AquaPT
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Primary Outcome(s)
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Change digestive discomfort symptoms at 6 weeks
[Time Frame: wk 0 & wk 6]
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Secondary Outcome(s)
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Change in at Cytokines 6 weeks
[Time Frame: Weeks 0 & 6]
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Change abdominal bloating at 6 weeks
[Time Frame: Week 0 & 6]
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Change in flatulence at 6 weeks
[Time Frame: Weeks 0 & 6]
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Change in tummy discomfort at 6 weeks
[Time Frame: Weeks 0 & 6]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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