Status:
COMPLETED
Clinical Trial Assessing the Efficacy and Safety of Hépar® in Chronic Constipation
Lead Sponsor:
Quanta Medical
Conditions:
Constipation - Functional
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
The study objectives are to evaluate the efficacy and safety of a 2-week daily intake of 1L Hépar® natural mineral water rich in magnesium sulphate compared to a control natural mineral water in the t...
Detailed Description
Healthy patients meeting all of the following criteria were included in the study: i) female outpatient aged 18 to 60, ii) with a diagnosis of functional constipation according to the Rome III criteri...
Eligibility Criteria
Inclusion
- Women, aged 18 to 60.
- Outpatients.
- Diagnosis of constipation according to the Rome III criteria Symptoms ≥3 months Onset ≥6 months prior to diagnosis
- a. Presence of ≥2 of the following symptoms for at least 25% of defecations: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of ano-rectal obstruction/blockage, manual maneuvers to facilitate defecation (e.g., digital evacuation, support of the pelvic floor), \<3 defecations/week and b. Loose stool rarely present without use of laxative and c. Insufficient criteria for Inflammatory Bowel Syndrome with constipation (IBS-C)
- No laxative drug for ≥ 3 days preceding the inclusion.
- Easy access to toilet at work or elsewhere.
- Regularly consumption of vegetables and fruits.
- Physical activity 2 or 3 times a week.
- Consumption of 1.0 L to 1.5 L of water per day.
- Signed informed consent.
- Ability to follow the study instructions.
- Health insurance coverage.
Exclusion
- Current pregnancy.
- Severe or acute disease likely to interfere with the results of the study or to be life-threatening.
- History of digestive disease, digestive malformation.
- Metabolic disease.
- Dysfunction of phospho-calcium metabolism.
- History of renal disease (renal insufficiency etc.) or cardio-vascular disease (cardiac insufficiency...), respiratory disease, neural disease.
- Subject on local or general treatment (prescribed drugs, food supplements etc.) likely to interfere with evaluation of the study parameters, including hydration status and transit.
- Subject who refuses to sign the declaration of informed consent.
- Subject not available for the entire duration of the study.
- Subject having a bad acceptance to Hépar® water.
- Subject being currently treated with drugs that can interact on digestive motility: paraffin, mucilages, pro or prebiotics, lactulose, lactitol, PEG.
- Subject has participated in a clinical trial within 3 months prior to baseline visit.
Key Trial Info
Start Date :
January 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2016
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT03348007
Start Date
January 30 2015
End Date
July 22 2016
Last Update
November 27 2017
Active Locations (1)
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1
Quanta Medical
Rueil-Malmaison, France, 92500