Healthy IndividualsNCT03728868
Tolerability and Risk of Adverse Events With a Probiotic Supplement
A study testing High dose F. prausnitzii and D. piger and Low dose F. prausnitzii and D. piger in people with Healthy Individuals, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- High dose F. prausnitzii and D. piger and Low dose F. prausnitzii and D. piger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 to 40 years old
- Signed consent for participation
- Healthy individuals without any known diseases
- Willingness and ability to attend to planned visits, participate in telephone interviews and follow study instructions
- Understanding the Swedish language in spoken and written terms
Who cannot join
- Ongoing treatment with prescription drugs
- Regular or sporadic intake of probiotic products (foods with probiotics are allowed)
- Treated with antibiotics during the last 3 months
- Pregnancy
- Have experienced gastrointestinal tract symptoms (during the last month), which could affect study participation, as deemed by study physician.
- Current tobacco use (smoking or snuff)
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
Gothenburg, Västra Götaland County, 43180
About this study
Official title: Tolerability and Risk of Adverse Events With a Probiotic Supplement: A Randomised and Placebo Controlled Study in Healthy Individuals
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.
Read the detailed description
The understanding of the role of the gastrointestinal microbes for human health has gained considerable interest in recent years. The butyrate-producing bacterium Faecalibacterium prausnitzii is a naturally occurring bacterial species in the human gut that can make up to 5% of the gastrointestinal flora in healthy individuals.
Several studies have shown that the presence of butyrate producing bacteria, including F. prausnitzii, is lower in patients with inflammatory bowel disease; Crohn's disease and ulcerative colitis. Furthermore, lower levels of short fatty acids have been found in people with ulcerative colitis as compared to healthy individuals. Similar results have been obtained from studies about Crohn's disease, where people with a low abundance of F. prausnitzii run a higher risk of post-operative recurrence of their disease.
It has become evident that bacteria in the human gastrointestinal tract are symbiotic and dependent on each other's metabolism. Studies conducted by the sponsor (Metabogen AB) have shown that butyrate production from F. prausnitzii increases in the presence of Desulfovibrio piger, a common sulphate-reducing bacterium present in the human intestine. The symbiotic relationship between F. prausnitzii and D. piger can be utilised by combining these bacterial species into a probiotic dietary supplement, thus maintaining butyrate production in the intestine.
In animal models, who received approximately 5,000 times higher doses per kilogram of body weight than the highest dose scheduled in the proposed study, the intake of F. prausnitzii has shown anti-inflammatory effects as well as positive effects on the metabolism.
The present study is a double-blind, placebo-controlled, randomized, study in 48 healthy individuals (men and women) between 20 and 40 years old recruited from the general population. These volunteers will either receive F. prausnitzii and D. piger (in two different doses) or placebo orally once a day for 8 consecutive weeks. The investigators will assess how well treatment with the study product compared to placebo is tolerated (termination due to adverse events within 8 weeks of treatment) and if it can cause gastrointestinal symptoms (measured with The Gastrointestinal Symptom Rating Scale). The investigators will also assess if the intake of the study product can potentially give positive effects in the metabolism (blood glucose, fatty acids, protein ect).
- Conditions
- Healthy Individuals
- Being tested
- Placebo, High dose F. prausnitzii and D. piger, Low dose F. prausnitzii and D. piger
- Keywords
- Faecalibacterium prausnitzii, Desulfovibrio piger, tolerability, blood glucose levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Dietary supplementation with placebo once a day for 8 consecutive weeks
High dose F. prausnitzii and D. pigerDietary supplement
Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
Low dose F. prausnitzii and D. pigerDietary supplement
Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One capsule containing placebo (identical to the capsule with active product (F. prausnitzii and D. piger) in taste and appearance but without the active component) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. Receives: Dietary Supplement: Placebo |
| High dose F. prausnitzii and D. piger | Active comparator | One capsule (containing F. prausnitzii and D. piger at a dose of 1E9-5x1E9 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. Receives: Dietary Supplement: High dose F. prausnitzii and D. piger |
| Low dose F. prausnitzii and D. piger | Active comparator | One capsule (containing F. prausnitzii and D. piger at a dose of 1E8-5x1E8 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. Receives: Dietary Supplement: Low dose F. prausnitzii and D. piger |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-8 weeks
Secondary outcomes (15)
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.
Measured: 0-8 weeks
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.
Measured: 0-8 weeks
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.
Measured: 0-8 weeks
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.
Measured: 0-8 weeks
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.
Measured: 0-8 weeks
Effect on hematopoiesis - platelets (safety parameters)
Changes in platelets count. Significant change in platelets count before and after the 8-week treatment period.
Measured: 0-8 weeks
Effects on liver enzymes - ALAT (safety parameters)
Changes in liver enzyme ALAT (Alanine transaminase). Significant changes before baseline and after 8 weeks of treatment.
Measured: 0-8 weeks
Effects on liver enzymes - ASAT (safety parameters)
Changes in liver enzyme ASAT (Aspartate transaminase). Significant changes before baseline and after 8 weeks of treatment.
Measured: 0-8 weeks
Effects on liver enzymes - ALP (safety parameters)
Changes in liver enzyme, ALP (Alkaline phosphatase). Significant changes before baseline and after 8 weeks of treatment.
Measured: 0-8 weeks
Effects on serum bilirubin (safety parameters)
Changes in serum bilirubin. Significant changes before baseline and after 8 weeks of treatment.
Measured: 0-8 weeks
Effects on the blood glucose
Changes (in percent) in levels of fasting blood glucose and HbA1c before and after the 8 week treatment period.
Measured: 0-8 weeks
Effects on abundance of short-chain fatty acids
Changes in short-chain fatty acids in stool from baseline to week 10.
Measured: 0-10 weeks
Colonization with F. prausnitzii
Colonization of the intestine with the total amount of F. prausnitzii bacteria. Measured in stool.
Measured: 0-8 weeks
Effect on renal function(safety parameter)
Change in calculated eGFR (Glomerular Filtration Rate, based on serum creatinine)
Measured: 0-8 weeks
Effect on serum total protein (safety parameter)
Change in serum total protein
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Oct 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MetaboGen AB
- Responsible party
- Principal investigator, Mattias Lorentzon, Sahlgrenska University Hospital
- Investigators
- Mattias Lorenzon, MD, PhD, Principal investigator, Dept Geriatrics, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728868
- Sponsor's protocol ID
- META002
- Status last verified
- Feb 2020
- First submitted
- 2 Oct 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.
PubMed 15505215Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.
PubMed 19043404Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
PubMed 23363771Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
PubMed 23985870Karlsson FH, Tremaroli V, Nookaew I, Bergstrom G, Behre CJ, Fagerberg B, Nielsen J, Backhed F. Gut metagenome in European women with normal, impaired and diabetic glucose control. Nature. 2013 Jun 6;498(7452):99-103. doi: 10.1038/nature12198. Epub 2013 May 29.
PubMed 23719380Qin J, Li Y, Cai Z, Li S, Zhu J, Zhang F, Liang S, Zhang W, Guan Y, Shen D, Peng Y, Zhang D, Jie Z, Wu W, Qin Y, Xue W, Li J, Han L, Lu D, Wu P, Dai Y, Sun X, Li Z, Tang A, Zhong S, Li X, Chen W, Xu R, Wang M, Feng Q, Gong M, Yu J, Zhang Y, Zhang M, Hansen T, Sanchez G, Raes J, Falony G, Okuda S, Almeida M, LeChatelier E, Renault P, Pons N, Batto JM, Zhang Z, Chen H, Yang R, Zheng W, Li S, Yang H, Wang J, Ehrlich SD, Nielsen R, Pedersen O, Kristiansen K, Wang J. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature. 2012 Oct 4;490(7418):55-60. doi: 10.1038/nature11450. Epub 2012 Sep 26.
PubMed 23023125Ott SJ, Musfeldt M, Wenderoth DF, Hampe J, Brant O, Folsch UR, Timmis KN, Schreiber S. Reduction in diversity of the colonic mucosa associated bacterial microflora in patients with active inflammatory bowel disease. Gut. 2004 May;53(5):685-93. doi: 10.1136/gut.2003.025403.
PubMed 15082587Loomba R, Seguritan V, Li W, Long T, Klitgord N, Bhatt A, Dulai PS, Caussy C, Bettencourt R, Highlander SK, Jones MB, Sirlin CB, Schnabl B, Brinkac L, Schork N, Chen CH, Brenner DA, Biggs W, Yooseph S, Venter JC, Nelson KE. Gut Microbiome-Based Metagenomic Signature for Non-invasive Detection of Advanced Fibrosis in Human Nonalcoholic Fatty Liver Disease. Cell Metab. 2017 May 2;25(5):1054-1062.e5. doi: 10.1016/j.cmet.2017.04.001.
PubMed 28467925Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.
PubMed 24315484Machiels K, Joossens M, Sabino J, De Preter V, Arijs I, Eeckhaut V, Ballet V, Claes K, Van Immerseel F, Verbeke K, Ferrante M, Verhaegen J, Rutgeerts P, Vermeire S. A decrease of the butyrate-producing species Roseburia hominis and Faecalibacterium prausnitzii defines dysbiosis in patients with ulcerative colitis. Gut. 2014 Aug;63(8):1275-83. doi: 10.1136/gutjnl-2013-304833. Epub 2013 Sep 10.
PubMed 24021287Sokol H, Pigneur B, Watterlot L, Lakhdari O, Bermudez-Humaran LG, Gratadoux JJ, Blugeon S, Bridonneau C, Furet JP, Corthier G, Grangette C, Vasquez N, Pochart P, Trugnan G, Thomas G, Blottiere HM, Dore J, Marteau P, Seksik P, Langella P. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008 Oct 28;105(43):16731-6. doi: 10.1073/pnas.0804812105. Epub 2008 Oct 20.
PubMed 18936492Khan MT, Dwibedi C, Sundh D, Pradhan M, Kraft JD, Caesar R, Tremaroli V, Lorentzon M, Backhed F. Synergy and oxygen adaptation for development of next-generation probiotics. Nature. 2023 Aug;620(7973):381-385. doi: 10.1038/s41586-023-06378-w. Epub 2023 Aug 2.
PubMed 37532933
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Risk of Adverse Events With a Probiotic Supplement: A Randomised and Placebo Controlled Study in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03728868
- Acronym / sponsor ID
- META002
- Conditions
- Healthy Individuals
- Keywords
- Faecalibacterium prausnitzii, Desulfovibrio piger, tolerability, blood glucose levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- MetaboGen AB
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The understanding of the role of the gastrointestinal microbes for human health has gained considerable interest in recent years. The butyrate-producing bacterium Faecalibacterium prausnitzii is a naturally occurring bacterial species in the human gut that can make up to 5% of the gastrointestinal flora in healthy individuals.
Several studies have shown that the presence of butyrate producing bacteria, including F. prausnitzii, is lower in patients with inflammatory bowel disease; Crohn's disease and ulcerative colitis. Furthermore, lower levels of short fatty acids have been found in people with ulcerative colitis as compared to healthy individuals. Similar results have been obtained from studies about Crohn's disease, where people with a low abundance of F. prausnitzii run a higher risk of post-operative recurrence of their disease.
It has become evident that bacteria in the human gastrointestinal tract are symbiotic and dependent on each other's metabolism. Studies conducted by the sponsor (Metabogen AB) have shown that butyrate production from F. prausnitzii increases in the presence of Desulfovibrio piger, a common sulphate-reducing bacterium present in the human intestine. The symbiotic relationship between F. prausnitzii and D. piger can be utilised by combining these bacterial species into a probiotic dietary supplement, thus maintaining butyrate production in the intestine.
In animal models, who received approximately 5,000 times higher doses per kilogram of body weight than the highest dose scheduled in the proposed study, the intake of F. prausnitzii has shown anti-inflammatory effects as well as positive effects on the metabolism.
The present study is a double-blind, placebo-controlled, randomized, study in 48 healthy individuals (men and women) between 20 and 40 years old recruited from the general population. These volunteers will either receive F. prausnitzii and D. piger (in two different doses) or placebo orally once a day for 8 consecutive weeks. The investigators will assess how well treatment with the study product compared to placebo is tolerated (termination due to adverse events within 8 weeks of treatment) and if it can cause gastrointestinal symptoms (measured with The Gastrointestinal Symptom Rating Scale). The investigators will also assess if the intake of the study product can potentially give positive effects in the metabolism (blood glucose, fatty acids, protein ect).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule containing placebo (identical to the capsule with active product (F. prausnitzii and D. piger) in taste and appearance but without the active component) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. |
| High dose F. prausnitzii and D. piger | Active comparator | Dietary Supplement: High dose F. prausnitzii and D. pigerOne capsule (containing F. prausnitzii and D. piger at a dose of 1E9-5x1E9 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. |
| Low dose F. prausnitzii and D. piger | Active comparator | Dietary Supplement: Low dose F. prausnitzii and D. pigerOne capsule (containing F. prausnitzii and D. piger at a dose of 1E8-5x1E8 colony forming units per bacterial strain) taken orally once a day (morning), one hour before breakfast on empty stomach, for 8 consecutive weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20 to 40 years old
- Signed consent for participation
- Healthy individuals without any known diseases
- Willingness and ability to attend to planned visits, participate in telephone interviews and follow study instructions
- Understanding the Swedish language in spoken and written terms
Key exclusion criteria (7 listed)
- Ongoing treatment with prescription drugs
- Regular or sporadic intake of probiotic products (foods with probiotics are allowed)
- Treated with antibiotics during the last 3 months
- Pregnancy
- Have experienced gastrointestinal tract symptoms (during the last month), which could affect study participation, as deemed by study physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDietary supplementation with placebo once a day for 8 consecutive weeks | Dietary supplement | Placebo |
| High dose F. prausnitzii and D. pigerDietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks | Dietary supplement | High dose F. prausnitzii and D. piger |
| Low dose F. prausnitzii and D. pigerDietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks | Dietary supplement | Low dose F. prausnitzii and D. piger |
Primary outcome
Tolerability of the oral intake of F. prausnitzii and D. piger, defined as study discontinuation due to adverse events under 8 weeks of treatment.
Time frame: 0-8 weeks
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.
15 secondary outcomes
Gastrointestinal side effects, measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 0-8 weeks
Effects on inflammation - erythrocyte sedimentation rate (safety parameters )
Time frame: 0-8 weeks
Effects on inflammation - CRP (safety parameters )
Time frame: 0-8 weeks
Effect on hematopoiesis - red blood cells (safety parameters)
Time frame: 0-8 weeks
Effect on hematopoiesis - white blood cells (safety parameters)
Time frame: 0-8 weeks
Effect on hematopoiesis - platelets (safety parameters)
Time frame: 0-8 weeks
Effects on liver enzymes - ALAT (safety parameters)
Time frame: 0-8 weeks
Effects on liver enzymes - ASAT (safety parameters)
Time frame: 0-8 weeks
Effects on liver enzymes - ALP (safety parameters)
Time frame: 0-8 weeks
Effects on serum bilirubin (safety parameters)
Time frame: 0-8 weeks
Effects on the blood glucose
Time frame: 0-8 weeks
Effects on abundance of short-chain fatty acids
Time frame: 0-10 weeks
Colonization with F. prausnitzii
Time frame: 0-8 weeks
Effect on renal function(safety parameter)
Time frame: 0-8 weeks
Effect on serum total protein (safety parameter)
Time frame: 0-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 15505215Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.
- Background: PubMed 19043404Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.
- Background: PubMed 23363771Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
- Background: PubMed 23985870Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
- Background: PubMed 23719380Karlsson FH, Tremaroli V, Nookaew I, Bergstrom G, Behre CJ, Fagerberg B, Nielsen J, Backhed F. Gut metagenome in European women with normal, impaired and diabetic glucose control. Nature. 2013 Jun 6;498(7452):99-103. doi: 10.1038/nature12198. Epub 2013 May 29.
- Background: PubMed 23023125Qin J, Li Y, Cai Z, Li S, Zhu J, Zhang F, Liang S, Zhang W, Guan Y, Shen D, Peng Y, Zhang D, Jie Z, Wu W, Qin Y, Xue W, Li J, Han L, Lu D, Wu P, Dai Y, Sun X, Li Z, Tang A, Zhong S, Li X, Chen W, Xu R, Wang M, Feng Q, Gong M, Yu J, Zhang Y, Zhang M, Hansen T, Sanchez G, Raes J, Falony G, Okuda S, Almeida M, LeChatelier E, Renault P, Pons N, Batto JM, Zhang Z, Chen H, Yang R, Zheng W, Li S, Yang H, Wang J, Ehrlich SD, Nielsen R, Pedersen O, Kristiansen K, Wang J. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature. 2012 Oct 4;490(7418):55-60. doi: 10.1038/nature11450. Epub 2012 Sep 26.
- Background: PubMed 15082587Ott SJ, Musfeldt M, Wenderoth DF, Hampe J, Brant O, Folsch UR, Timmis KN, Schreiber S. Reduction in diversity of the colonic mucosa associated bacterial microflora in patients with active inflammatory bowel disease. Gut. 2004 May;53(5):685-93. doi: 10.1136/gut.2003.025403.
- Background: PubMed 28467925Loomba R, Seguritan V, Li W, Long T, Klitgord N, Bhatt A, Dulai PS, Caussy C, Bettencourt R, Highlander SK, Jones MB, Sirlin CB, Schnabl B, Brinkac L, Schork N, Chen CH, Brenner DA, Biggs W, Yooseph S, Venter JC, Nelson KE. Gut Microbiome-Based Metagenomic Signature for Non-invasive Detection of Advanced Fibrosis in Human Nonalcoholic Fatty Liver Disease. Cell Metab. 2017 May 2;25(5):1054-1062.e5. doi: 10.1016/j.cmet.2017.04.001.
- Background: PubMed 24315484Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.
- Background: PubMed 24021287Machiels K, Joossens M, Sabino J, De Preter V, Arijs I, Eeckhaut V, Ballet V, Claes K, Van Immerseel F, Verbeke K, Ferrante M, Verhaegen J, Rutgeerts P, Vermeire S. A decrease of the butyrate-producing species Roseburia hominis and Faecalibacterium prausnitzii defines dysbiosis in patients with ulcerative colitis. Gut. 2014 Aug;63(8):1275-83. doi: 10.1136/gutjnl-2013-304833. Epub 2013 Sep 10.
- Background: PubMed 18936492Sokol H, Pigneur B, Watterlot L, Lakhdari O, Bermudez-Humaran LG, Gratadoux JJ, Blugeon S, Bridonneau C, Furet JP, Corthier G, Grangette C, Vasquez N, Pochart P, Trugnan G, Thomas G, Blottiere HM, Dore J, Marteau P, Seksik P, Langella P. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008 Oct 28;105(43):16731-6. doi: 10.1073/pnas.0804812105. Epub 2008 Oct 20.
- Derived from this study: PubMed 37532933Khan MT, Dwibedi C, Sundh D, Pradhan M, Kraft JD, Caesar R, Tremaroli V, Lorentzon M, Backhed F. Synergy and oxygen adaptation for development of next-generation probiotics. Nature. 2023 Aug;620(7973):381-385. doi: 10.1038/s41586-023-06378-w. Epub 2023 Aug 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Lorenzon, MD, PhD principal investigator
Dept Geriatrics, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose F. prausnitzii and D. piger and Low dose F. prausnitzii and D. piger in people with Healthy Individuals, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the oral intake of F. prausnitzii and D. piger, defined as study discontinuation due to adverse events under 8 weeks of treatment. (time frame: 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728868, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.