Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS)NCT06915129
The Effect of Galactooligosaccharides (GOS) on the Gut Microbiota of Lactose Intolerance Individuals
A study testing Prebiotic galactooligosaccharides (GOS) in people with Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS), run by Oregon State University at 1 site in United States.
Trial summary
The purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS)
- What is being tested?
- Prebiotic galactooligosaccharides (GOS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 6 Dec 2021
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- People with lactose intolerance (formal and informal diagnosis) Fluent in English People who have a primary care provider Have to be 18 years and older
Who cannot join
- Any known gastrointestinal disease or disorder, or major gastrointestinal surgery Habitual use of laxatives or antacids Diabetes Pregnancy Use of antibiotics within one month prior to the study Use of pre or probiotics within one month prior to the study Any subject who, in the opinion of a physician, has a medical or psychological condition that would preclude them from completing the study Dairy protein allergy (not lactose intolerance) Use of lactose intolerance pills such as "Lactaid" should be avoided during the course of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Galactooligosaccharides (GOS) Promote the Proliferation of Bifidobacteria and May be a Viable Management Strategy for Lactose Intolerance Symptoms
The purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects.
Read the detailed description
The experimental design of this study was a completely randomized placebo-controlled clinical trial study, which consisted of a one-week screening period followed by a 3-week supplementation period and a 3 week-washout period. Institutional Review Board (IRB) approval was obtained through Oregon State University's Regional Institutional Review Board (IRB Number IRB-2021-1044) and written informed consent was obtained from all participants.
During the supplementation period, participants were instructed to consume twice daily (morning and evening) either prebagged 5.2 g of GOS (treatment group) or 1 g of lactose (placebo), which the participants were instructed to dissolve in 250ml of water and consume either before or after meals. The GOS (donated by FrieslandCampina, Amersfoort, the Netherlands, and sold under the trade name, BiotisTM GOS-O Powder) contained 73.7% GOS, 20.9% lactose, and 5.3% monosaccharides (galactose and glucose) and 1.0% ash. To account for the nutritional impact of lactose in the GOS supplement on host and microbiota, 1 g lactose, donated by Glanbia Nutritionals (Twin Falls, ID, USA), was given as a control in this study.
12 adults (2 males, 10 females), ages 19-55 years (mean: 29 years; SD: 11 years) started the clinical trial. During the study, participants continued with their regular diets that they recorded weekly in a food frequency questionnaire. The only dietary restrictions were: no consumption of dairy pills such as Lactaid, no pre/probiotic supplements, and antibiotics.
Fecal samples were collected weekly for the duration of the study. Participants used the Easy Sampler ® Stool Collection kit (ALPCO®, New Hampshire, USA) to collect samples and they dropped them off in the lab immediately after collection.
DNA was extracted from 200 mg of fecal samples via a QIAamp Powerfeccal Pro(Qiagen, Hilden, Germany).
The concentration of extracted DNA was measured via a Qubit 4 Fluorometer (Thermo Fisher Scientific, Waltham, MA) followed by a library construction targeting the V4 region of the 16S rRNA gene for microbiome sequencing.
Microbiome compositional analysis and statistical analysis were performed to identify shifts in specific microbes over time with prebiotic GOS supplementation and lactose supplementation.
Selected lactose-fermenting-related biomarker microorganisms were kept track of for any significant increases or decreases in relative abundance as well as any other microbes that have not been previously reported.
For the duration of the study, participants recorded gastrointestinal symptoms every other day in an unvalidated, online questionnaire which was specifically designed for this study to capture the incidence and severity of LI symptoms (abdominal pain, bloating, burping, constipation, diarrhea, discomfort during defecation, flatulence, heart burn, incomplete defecation, nausea, urgency to defecate).
To evaluate the impact of diet on microbial diversity and gastrointestinal symptoms, we correlated weekly food group intake with weekly measure of microbial diversity and gastrointestinal symptoms overall, within GOS, and within Control using Spearman correlation in SAS.
- Being tested
- Prebiotic galactooligosaccharides (GOS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic galactooligosaccharides (GOS)Dietary supplement
Galactooligosaccharides (GOSs) are a group of nondigestible oligosaccharides consisting of galactose units linked via glycosidic bonds to galactose, terminal glucose, or sucrose. The linkages are not digested by human and animal pancreatic or intestinal enzymes. Some recent papers reported that daily supplementation with prebiotic GOS to lactose-intolerant individuals altered the gut microbiome and decreased lactose intolerance (LI) symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Galactooligosaccharides group(GOS)) | Experimental | During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 5.2 g of galactooligosaccharide (GOS) which the participants were instructed to dissolve in 250 ml of water and consume either before or after meals. Receives: Dietary Supplement: Prebiotic galactooligosaccharides (GOS) |
| Control group (lactose group) | Placebo comparator | During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 1 g of lactose which the participant was instructed to dissolve in 250 ml of water and consume either before or after meals. Receives: Dietary Supplement: Prebiotic galactooligosaccharides (GOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera
DNA was extracted from 200 mg of fecal samples Hilden, Germany). The concentration of extracted DNA was measured by Fluorometer, followed by a library construction targeting the V4 region of the 16S rRNA gene for microbiome sequencing.
Microbiome compositional analysis and statistical analysis was performed to identify shifts in specific microbes over time with prebiotic GOS supplementation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start25 Oct 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental design was a completely randomized placebo-controlled clinical trial study, which consisted of a one-week screening period followed by a 3-week supplementation period and a 3 week-washout period
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dave Dallas, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915129
- Sponsor's protocol ID
- IRB-2021-1044
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galactooligosaccharides (GOS) Promote the Proliferation of Bifidobacteria and May be a Viable Management Strategy for Lactose Intolerance Symptoms
- ClinicalTrials.gov ID
- NCT06915129
- Acronym / sponsor ID
- IRB-2021-1044
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 8 Apr 2025 (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 purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects.
Detailed description
The experimental design of this study was a completely randomized placebo-controlled clinical trial study, which consisted of a one-week screening period followed by a 3-week supplementation period and a 3 week-washout period. Institutional Review Board (IRB) approval was obtained through Oregon State University's Regional Institutional Review Board (IRB Number IRB-2021-1044) and written informed consent was obtained from all participants.
During the supplementation period, participants were instructed to consume twice daily (morning and evening) either prebagged 5.2 g of GOS (treatment group) or 1 g of lactose (placebo), which the participants were instructed to dissolve in 250ml of water and consume either before or after meals. The GOS (donated by FrieslandCampina, Amersfoort, the Netherlands, and sold under the trade name, BiotisTM GOS-O Powder) contained 73.7% GOS, 20.9% lactose, and 5.3% monosaccharides (galactose and glucose) and 1.0% ash. To account for the nutritional impact of lactose in the GOS supplement on host and microbiota, 1 g lactose, donated by Glanbia Nutritionals (Twin Falls, ID, USA), was given as a control in this study.
12 adults (2 males, 10 females), ages 19-55 years (mean: 29 years; SD: 11 years) started the clinical trial. During the study, participants continued with their regular diets that they recorded weekly in a food frequency questionnaire. The only dietary restrictions were: no consumption of dairy pills such as Lactaid, no pre/probiotic supplements, and antibiotics.
Fecal samples were collected weekly for the duration of the study. Participants used the Easy Sampler ® Stool Collection kit (ALPCO®, New Hampshire, USA) to collect samples and they dropped them off in the lab immediately after collection.
DNA was extracted from 200 mg of fecal samples via a QIAamp Powerfeccal Pro(Qiagen, Hilden, Germany).
The concentration of extracted DNA was measured via a Qubit 4 Fluorometer (Thermo Fisher Scientific, Waltham, MA) followed by a library construction targeting the V4 region of the 16S rRNA gene for microbiome sequencing.
Microbiome compositional analysis and statistical analysis were performed to identify shifts in specific microbes over time with prebiotic GOS supplementation and lactose supplementation.
Selected lactose-fermenting-related biomarker microorganisms were kept track of for any significant increases or decreases in relative abundance as well as any other microbes that have not been previously reported.
For the duration of the study, participants recorded gastrointestinal symptoms every other day in an unvalidated, online questionnaire which was specifically designed for this study to capture the incidence and severity of LI symptoms (abdominal pain, bloating, burping, constipation, diarrhea, discomfort during defecation, flatulence, heart burn, incomplete defecation, nausea, urgency to defecate).
To evaluate the impact of diet on microbial diversity and gastrointestinal symptoms, we correlated weekly food group intake with weekly measure of microbial diversity and gastrointestinal symptoms overall, within GOS, and within Control using Spearman correlation in SAS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experimental design was a completely randomized placebo-controlled clinical trial study, which consisted of a one-week screening period followed by a 3-week supplementation period and a 3 week-washout period
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Galactooligosaccharides group(GOS)) | Experimental | Dietary Supplement: Prebiotic galactooligosaccharides (GOS)During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 5.2 g of galactooligosaccharide (GOS) which the participants were instructed to dissolve in 250 ml of water and consume either before or after meals. |
| Control group (lactose group) | Placebo comparator | Dietary Supplement: Prebiotic galactooligosaccharides (GOS)During the supplementation period, participants were instructed to consume twice daily (morning and evening) prebagged 1 g of lactose which the participant was instructed to dissolve in 250 ml of water and consume either before or after meals. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- People with lactose intolerance (formal and informal diagnosis) Fluent in English People who have a primary care provider Have to be 18 years and older
Key exclusion criteria (1 listed)
- Any known gastrointestinal disease or disorder, or major gastrointestinal surgery Habitual use of laxatives or antacids Diabetes Pregnancy Use of antibiotics within one month prior to the study Use of pre or probiotics within one month prior to the study Any subject who, in the opinion of a physician, has a medical or psychological condition that would preclude them from completing the study Dairy protein allergy (not lactose intolerance) Use of lactose intolerance pills such as "Lactaid" should be avoided during the course of this 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 |
|---|---|---|
| Prebiotic galactooligosaccharides (GOS)Galactooligosaccharides (GOSs) are a group of nondigestible oligosaccharides consisting of galactose units linked via glycosidic bonds to galactose, terminal glucose, or sucrose. The linkages are not digested by human and animal pancreatic or intestinal enzymes. Some recent papers reported that daily supplementation with prebiotic GOS to lactose-intolerant individuals altered the gut microbiome and decreased lactose intolerance (LI) symptoms. | Dietary supplement | Control group (lactose group), Treatment group (Galactooligosaccharides group(GOS)) |
Primary outcome
Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera
Time frame: 6 weeks
DNA was extracted from 200 mg of fecal samples Hilden, Germany). The concentration of extracted DNA was measured by Fluorometer, followed by a library construction targeting the V4 region of the 16S rRNA gene for microbiome sequencing. Microbiome compositional analysis and statistical analysis was performed to identify shifts in specific microbes over time with prebiotic GOS supplementation.
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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic galactooligosaccharides (GOS) in people with Modulation of the Human Gut Microbiota by Prebiotic Galactooligosaccharides (GOS), run by Oregon State University at 1 site in United States.
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 1 inclusion and 1 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 8 Apr 2025. 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 United States. 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?
Increase in the relative abundance of the genus Bifidobacterium and other lactose-metabolizing genera (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.