Colonic Diseases [C06.405.469.158]GOSNCT01848535
Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
A study testing GOS addition in people with Colonic Diseases [C06.405.469.158], run by Wageningen University at 1 site in Netherlands.
Trial summary
Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS)… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Diseases [C06.405.469.158]
- What is being tested?
- GOS addition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Jul 2013
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40 *
- BMI: 18.5-25 kg/m2
- Stable weight over the last 6 months
- Western diet
- Availability of information about birth by caesarean section and breast-feeding
- Regular defecation (~1day)
- Healthy as judge by the participant himself
- Having signed the informed consent form
Who cannot join
- Smoking or drug use
- Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman
- Using contraceptive pill
- Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease)
- Traveling to an Asian, African or south American country < 6 months before the study
- Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin)
Show all 12Show fewer
- Having hepatic disease and renal failure
- Using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma
- Not willing to have the family doctor be informed about participation to the study.
- Antibiotic use < 3 months before the study
- More than 3 antibiotic treatments in the last 2 years.
- Probiotic or prebiotic use < 1 month before the study*
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle.
Objective:
Read more
To explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo.
Study population:
10 healthy men and women volunteers, 18 - 40 yr old
- Conditions
- Colonic Diseases [C06.405.469.158]
- Being tested
- GOS addition, Placebo
- Keywords
- intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOS additionDietary supplement
Also called Galacto-oligosaccharide, Vivinal GOS
GOS (2.5g 3x per day) supplemented during 12 days
PlaceboDietary supplement
Also called maltodextrine
Maltodextrine(2.5g 3x per day) supplemented during 12 days
| Study group | Role | What they receive |
|---|---|---|
| GOS addition | Placebo comparator | All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. Receives: Dietary Supplement: GOS addition; Dietary Supplement: Placebo |
| placebo (maltodextrine) | Placebo comparator | All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. Receives: Dietary Supplement: GOS addition; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition
Microbiota composition of the collected faecal sample will be investigated using a phylogenetic microarray, the Intestinal-Chip. With this microarray, more than 400 species of the intestinal microbiota can be detected.
Bifidobacteria and Lactobacillus as beneficial bacteria as well as Enterobacteriaceae and possible other pathogens (Cells/ g faecal dry weight) will also be measured using a real-time PCR with specific primers.
Measured: evaluation between july and september 2013
Secondary outcomes (1)
Microbiota activity
The Short Chain Fatty acid (SCFA) amount produced will be measured using chromatographic approaches (Gas Chromatography, High Performance Liquid Chromatography).
The remaining GOS will be measured with High Performance Anion Exchange Chromatography (HPAEC) or with Capillary Electrophoresis -Light Induced Fluorescence, which has a better resolution than HPAEC.
Measured: evaluation between july and september 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic Diseases [C06.405.469.158]Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Ladirat, MSc, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848535
- Sponsor's protocol ID
- ABRnr42438
- Other IDs
- WUR42438
- Acronym
- GOS
- Status last verified
- Nov 2013
- First submitted
- 16 Apr 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saulnier DM, Kolida S, Gibson GR. Microbiology of the human intestinal tract and approaches for its dietary modulation. Curr Pharm Des. 2009;15(13):1403-14. doi: 10.2174/138161209788168128.
PubMed 19442165
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
- ClinicalTrials.gov ID
- NCT01848535
- Acronym / sponsor ID
- GOS / ABRnr42438
- Conditions
- Colonic Diseases [C06.405.469.158]
- Keywords
- intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle.
Objective:
To explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo.
Study population:
10 healthy men and women volunteers, 18 - 40 yr old
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOS addition | Placebo comparator | Dietary Supplement: GOS addition, Dietary Supplement: PlaceboAll subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. |
| placebo (maltodextrine) | Placebo comparator | Dietary Supplement: GOS addition, Dietary Supplement: PlaceboAll subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18-40 *
- BMI: 18.5-25 kg/m2
- Stable weight over the last 6 months
- Western diet
- Availability of information about birth by caesarean section and breast-feeding
Key exclusion criteria (12 listed)
- Smoking or drug use
- Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman
- Using contraceptive pill
- Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease)
- Traveling to an Asian, African or south American country < 6 months before the study
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 |
|---|---|---|
| GOS additionAlso: Galacto-oligosaccharide, Vivinal GOSGOS (2.5g 3x per day) supplemented during 12 days | Dietary supplement | GOS addition, placebo (maltodextrine) |
| PlaceboAlso: maltodextrineMaltodextrine(2.5g 3x per day) supplemented during 12 days | Dietary supplement | GOS addition, placebo (maltodextrine) |
Primary outcome
Microbiota composition
Time frame: evaluation between july and september 2013
Microbiota composition of the collected faecal sample will be investigated using a phylogenetic microarray, the Intestinal-Chip. With this microarray, more than 400 species of the intestinal microbiota can be detected. Bifidobacteria and Lactobacillus as beneficial bacteria as well as Enterobacteriaceae and possible other pathogens (Cells/ g faecal dry weight) will also be measured using a real-time PCR with specific primers.
1 secondary outcome
Microbiota activity
Time frame: evaluation between july and september 2013
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 20 Nov 2013.
- Background: PubMed 19442165Saulnier DM, Kolida S, Gibson GR. Microbiology of the human intestinal tract and approaches for its dietary modulation. Curr Pharm Des. 2009;15(13):1403-14. doi: 10.2174/138161209788168128.
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.
Stephanie Ladirat, MSc principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOS addition in people with Colonic Diseases [C06.405.469.158], run by Wageningen University at 1 site in Netherlands.
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 8 inclusion and 12 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 20 Nov 2013. 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 Netherlands. 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?
Microbiota composition (time frame: evaluation between july and september 2013). 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 NCT01848535, which also lists 1 linked publication.
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 20 Nov 2013.