Healthy Individuals Clinical Trial
Official title:
Tolerability and Risk of Adverse Events With a Probiotic Supplement: A Randomised and Placebo Controlled Study in Healthy Individuals
NCT number | NCT03728868 |
Other study ID # | META002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2018 |
Est. completion date | May 31, 2019 |
Verified date | February 2020 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel
and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced
presence of it has been associated with an imbalance in the gastrointestinal flora of
metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease.
The present double-blind, placebo-controlled, randomized study is designed to investigate if
dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8
consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a
positive way.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. 20 to 40 years old 2. Signed consent for participation 3. Healthy individuals without any known diseases 4. Willingness and ability to attend to planned visits, participate in telephone interviews and follow study instructions 5. Understanding the Swedish language in spoken and written terms Exclusion Criteria: 1. Ongoing treatment with prescription drugs 2. Regular or sporadic intake of probiotic products (foods with probiotics are allowed) 3. Treated with antibiotics during the last 3 months 4. Pregnancy 5. Have experienced gastrointestinal tract symptoms (during the last month), which could affect study participation, as deemed by study physician. 6. Current tobacco use (smoking or snuff) 7. Participation in another clinical study |
Country | Name | City | State |
---|---|---|---|
Sweden | Geriatric Medicine, Sahlgrenska University Hospital, Mölndal | Gothenburg | Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Metabogen AB |
Sweden,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerability of the oral intake of F. prausnitzii and D. piger, defined as study discontinuation due to adverse events under 8 weeks of treatment. | How well treatment with the study product compared to placebo is tolerated, which is primarily defined as termination due to adverse events under 8 weeks of treatment. | 0-8 weeks | |
Secondary | Gastrointestinal side effects, measured using the Gastrointestinal Symptom Rating Scale (GSRS) | Gastrointestinal symptoms are measured with The Gastrointestinal Symptom Rating Scale (GSRS), which includes 15 items combined into five symptom clusters measuring 1) reflux, 2) abdominal pain, 3) indigestion, 4) diarrhoea and 5) constipation. GSRS has a seven-point graded Likert-type scale, in which 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total score is derived from all subclasses, resulting in a score between 0 and 45. | 0-8 weeks | |
Secondary | Effects on inflammation - erythrocyte sedimentation rate (safety parameters ) | Change in erythrocyte sedimentation rate in blood. Significant change in erythrocyte sedimentation rate before and after the 8-week treatment period. | 0-8 weeks | |
Secondary | Effects on inflammation - CRP (safety parameters ) | Change in C-reactive protein (CRP) level in blood. Significant change in CRP before and after the 8-week treatment period. | 0-8 weeks | |
Secondary | Effect on hematopoiesis - red blood cells (safety parameters) | Changes in red blood cells count. Significant change in red blood cell count before and after the 8-week treatment period. | 0-8 weeks | |
Secondary | Effect on hematopoiesis - white blood cells (safety parameters) | Changes in white blood cells count. Significant change in white blood cells count before and after the 8-week treatment period. | 0-8 weeks | |
Secondary | Effect on hematopoiesis - platelets (safety parameters) | Changes in platelets count. Significant change in platelets count before and after the 8-week treatment period. | 0-8 weeks | |
Secondary | Effects on liver enzymes - ALAT (safety parameters) | Changes in liver enzyme ALAT (Alanine transaminase). Significant changes before baseline and after 8 weeks of treatment. | 0-8 weeks | |
Secondary | Effects on liver enzymes - ASAT (safety parameters) | Changes in liver enzyme ASAT (Aspartate transaminase). Significant changes before baseline and after 8 weeks of treatment. | 0-8 weeks | |
Secondary | Effects on liver enzymes - ALP (safety parameters) | Changes in liver enzyme, ALP (Alkaline phosphatase). Significant changes before baseline and after 8 weeks of treatment. | 0-8 weeks | |
Secondary | Effects on serum bilirubin (safety parameters) | Changes in serum bilirubin. Significant changes before baseline and after 8 weeks of treatment. | 0-8 weeks | |
Secondary | Effects on the blood glucose | Changes (in percent) in levels of fasting blood glucose and HbA1c before and after the 8 week treatment period. | 0-8 weeks | |
Secondary | Effects on abundance of short-chain fatty acids | Changes in short-chain fatty acids in stool from baseline to week 10. | 0-10 weeks | |
Secondary | Colonization with F. prausnitzii | Colonization of the intestine with the total amount of F. prausnitzii bacteria. Measured in stool. | 0-8 weeks | |
Secondary | Effect on renal function(safety parameter) | Change in calculated eGFR (Glomerular Filtration Rate, based on serum creatinine) | 0-8 weeks | |
Secondary | Effect on serum total protein (safety parameter) | Change in serum total protein | 0-8 weeks |
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