Constipation Clinical Trial
Official title:
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.
Status | Completed |
Enrollment | 290 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Age = 65 years - Informed consent signed by study participant or legal guardian Exclusion Criteria: - Known gastrointestinal disease, with strictures, malignance's and ischemia. - Inflammatory bowel diseases (IBD) - Participation in other clinical trials in the past three months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Örebro University | Örebro | Närke |
Lead Sponsor | Collaborator |
---|---|
Örebro University, Sweden | BioGaia AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in mood during the 3month intervention period | Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs) | at baseline, 2months and 3monts/study end | No |
Other | Change in quality of life during the 3-month intervention period | Quality of life will be assessed through the EuroQol questionnaire. | at baseline, at baseline, 2months and 3monts/study end | No |
Primary | Change from baseline Gastrointestinal symptoms to 3months | Gastrointestinal discomfort will be assessed through the gastrointestinal symptoms rating score (GSRS), a clinical rating scale for gastrointestinal symptoms. The GSRS includes 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative. | Baseline, at 2 months and at 3months/study end | No |
Secondary | Change in use of intestinal motility regulating substances during the 3-month intervention period | Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication) | at baseline and end of study ( 3months) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Recruiting |
NCT06292949 -
Clinical Study of Resistant Starch in Improving Constipation
|
N/A | |
Recruiting |
NCT04132661 -
MRI Assessment of Mode of Action of Bisacodyl, Single Dose
|
Phase 4 | |
Terminated |
NCT02839889 -
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)
|
Phase 4 | |
Completed |
NCT02726295 -
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
|
Phase 4 | |
Recruiting |
NCT02255747 -
Anal Dilatation for Infants and Children With Constipation
|
N/A | |
Completed |
NCT02246647 -
Biomarkers for Intestinal Permeability in Patients With Constipation
|
||
Completed |
NCT01566409 -
Maintenance Treatment for Children With Constipation
|
N/A | |
Completed |
NCT02658201 -
Ultrafast MRI Imaging to Exclude Constipation
|
N/A | |
Completed |
NCT01695915 -
Diurnal Variation in Rectal Diameter
|
N/A | |
Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
Completed |
NCT02863848 -
Effect of Inulin-type Fructans on Constipated Children.
|
N/A | |
Completed |
NCT01411501 -
Efficacy and Safety of Acupuncture for Functional Constipation
|
Phase 3 | |
Completed |
NCT01474499 -
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
|
Phase 3 | |
Completed |
NCT01438567 -
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
Phase 3 | |
Completed |
NCT01170039 -
The Effectiveness of Lubiprostone in Constipated Diabetics
|
Phase 4 | |
Completed |
NCT00931853 -
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
|
Phase 3 | |
Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
Completed |
NCT00994851 -
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |