Gut -MicrobiotaC-prebioticsNCT07097389
In Vivo Human Study on Commercial Cellobiose as a Potential Prebiotic Candidate
A study testing Cellobiose and Oligofructose P95 in people with Gut -Microbiota and As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not, run by Manxi Huang at 1 site in United Kingdom.
Trial summary
The goal of this project is to investigate whether cellobiose, a type of sugar, has a beneficial effect on gut health when consumed by humans. Cellobiose will be obtained from spent coffee grounds through enzymatic modification, repurposing waste biomass for a potentially valuable purpose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut -Microbiota, As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not
- What is being tested?
- Cellobiose and Oligofructose P95
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2024to 1 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 years old and above
- Participants are willing to comply with the study instructions
- Participants have a stool frequency of at least 3 bowel movements per week
- Participants are healthy at the time of signing the consent form
Who cannot join
- Not pregnant or planning to be pregnant
- Previously or currently diagnosed gastrointestinal diseases and disorders that might affect the gut environment.
- Food allergies or intolerances
- Previously or currently diagnosed with cancer or taking a long-term medication.
- Use of medication (e.g, antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
- Participants are currently involved or will be involved in another clinical or food study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to investigate whether cellobiose, a type of sugar, has a beneficial effect on gut health when consumed by humans. Cellobiose will be obtained from spent coffee grounds through enzymatic modification, repurposing waste biomass for a potentially valuable purpose. The study will only focus on conducting in vivo human trials using a commercial form of cellobiose from Savanna Ingredients GmbH, which has recently been approved as a novel food by the EU (https://eur-lex.europa.eu/eli/reg_impl/2023/943/oj)
We will also be testing two other commercial products: Orafti® P95, an oligofructose-based product from Beneo GmbH, and maltodextrin from Special Ingredients Limited. These products will be compared to evaluate their potential in promoting gut health by nourishing beneficial bacteria, The study will involve feeding these products to volunteers and observing their impact on gut health.
Read more
The key questions this project aims to address include:
- Does cellobiose, exhibit any gut health promoting effects in humans?
- How does cellobiose compare to other commercial prebiotic products, such as Orafti® P95, in terms of its effects on gut health?
To conduct the study, volunteers will be provided with the three different products to consume over a specified period. Their faecal samples will be collected at various points to assess changes in gut microbiota composition and other indicators of gut health. This will involve close monitoring of participants' health and adherence to ethical guidelines to ensure their safety and well-being throughout the study.
Overall, this project seeks to expand our understanding of the potential health benefits of cellobiose and other prebiotic carbohydrates. It aims to provide valuable insights into the role of these substances in promoting gut health.
Read the detailed description
In this randomised, double-blinded, parallel-group trial, the investigators will enroll 36 healthy adult volunteers and randomise them 1:1:1 to one of three dietary-supplement arms. Participants will consume their assigned product once daily-5 g during a one-week adaptation phase followed by 10 g/day for a three-week intervention phase. Faecal samples will be collected at baseline (Visit 1) and at study completion (Visit 5). Total bacterial counts will be determined by fluorescence in situ hybridisation coupled with flow cytometry (FISH-FLOW), and short-chain fatty acid concentrations quantified by gas chromatography-flame ionisation detection (GC-FID).
The primary outcomes are the change from baseline to Visit 5 in (1) absolute abundance of Bifidobacterium spp. and Lactobacillus spp., and (2) total faecal short-chain fatty acid concentration. Secondary outcomes include gut microbiota diversity metrics (α- and β-diversity) and daily gastrointestinal symptom incidence. Exploratory outcomes will assess correlations between shifts in specific bacterial taxa and metabolite profiles, as well as changes in the abundance of other key genera.
- Conditions
- Gut -Microbiota, As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not
- Being tested
- Cellobiose, Oligofructose P95, Maltodextrin (Placebo)
- Keywords
- cellobiose, preliminary in vivo human study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellobioseDietary supplement
Cellobiose powder (Savanna Ingredients GmbH), 5 g per day and 10 g per day, mixed into ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.
Oligofructose P95Dietary supplement
Oligofructose (Orafti® P95, Beneo GmbH), 5 g per day and 10 g per day, dissolved in ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.
Maltodextrin (Placebo)Dietary supplement
Maltodextrin powder (Special Ingredients Limited), 5 g per day and 10 g per day, dissolved in ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Participants receive 5 g/day for the first 7 days and 10 g/day maltodextrin for the rest of the 21 days as a non-prebiotic control. Receives: Dietary Supplement: Maltodextrin (Placebo) |
| Orafti P95 (oligofructose P95) | Active comparator | Healthy adult volunteers will consume 5 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the first 7 days, and consume 10 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the rest of the 21 days. Receives: Dietary Supplement: Oligofructose P95 |
| Cellobiose | Experimental | Participants receive 5g/day for the first 7 days and 10 g/day cellobiose for 21 days. Receives: Dietary Supplement: Cellobiose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute abundance of faecal Bifidobacterium spp. and Lactobacillus spp.
Absolute abundance of Bifidobacterium spp. and Lactobacillus spp. in faecal microbiota, determined by 16S rRNA gene sequencing (Illumina NGS sequencing) and FLOW-FISH for total bacterial counts
Measured: Baseline (Day 0; Visit 1) to end of the intervention period (Day 28; Visit 5)
Change in total faecal short-chain fatty acid concentration
Sum of acetate, propionate, and butyrate concentrations in faecal samples, measured by GC-MS.
Measured: Baseline (Day 0; Visit 1) to end of the intervention(Day 28; Visit 5)
Secondary outcomes (2)
Magnitude and pattern of overall gut-microbiota shifts from V1 to V5
The magnitude and pattern of gut-microbiota compositional shifts from baseline (V1) to end-point (V5), quantified by each subject's within-pair Bray-Curtis distance and visualized via PCoA, with statistical significance assessed by a paired PERMANOVA (Visit as fixed effect, Subject as blocking factor).
Measured: Baseline (V1) through end-point (V5) of the 28-day intervention
Number of participants with Gastrointestinal Tolerability & Safety
Participants completed a daily diary during Days 1-28 of the intervention in which they:
Recorded the time of product ingestion.
Tick-boxed any GI symptoms each day from the following list:
Bloating, Gas/Flatulence, Abdominal pain/cramps, Diarrhoea
Nausea, Vomiting, Frequency of bowel movements, Constipation, Changes in stool consistency
If "Changes in stool consistency" was ticked, they described the change in a free-text field (e.g., "looser," "harder").
Measured: Days 1 through 28 of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Jul 2024
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut -MicrobiotaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manxi Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manxi Huang, University of Reading
- Investigators
- Bob Rastall, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097389
- Sponsor's protocol ID
- UREC24/20
- Acronym
- C-prebiotics
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcomes (microbiome absolute counts, SCFA concentrations, GI symptom diaries), along with the study protocol and statistical analysis plan, will be made available to qualified researchers beginning six months after publication. Requests can be submitted to the corresponding author (r.a.rastall@reading.ac.uk) and will require a signed data-use agreement. Data will be shared in CSV format.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Human Study on Commercial Cellobiose as a Potential Prebiotic Candidate
- ClinicalTrials.gov ID
- NCT07097389
- Acronym / sponsor ID
- C-prebiotics / UREC24/20
- Conditions
- Gut -Microbiota, As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not
- Keywords
- cellobiose, preliminary in vivo human study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Manxi HuangUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 31 Jul 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 goal of this project is to investigate whether cellobiose, a type of sugar, has a beneficial effect on gut health when consumed by humans. Cellobiose will be obtained from spent coffee grounds through enzymatic modification, repurposing waste biomass for a potentially valuable purpose. The study will only focus on conducting in vivo human trials using a commercial form of cellobiose from Savanna Ingredients GmbH, which has recently been approved as a novel food by the EU (https://eur-lex.europa.eu/eli/reg_impl/2023/943/oj)
We will also be testing two other commercial products: Orafti® P95, an oligofructose-based product from Beneo GmbH, and maltodextrin from Special Ingredients Limited. These products will be compared to evaluate their potential in promoting gut health by nourishing beneficial bacteria, The study will involve feeding these products to volunteers and observing their impact on gut health.
The key questions this project aims to address include:
- Does cellobiose, exhibit any gut health promoting effects in humans?
- How does cellobiose compare to other commercial prebiotic products, such as Orafti® P95, in terms of its effects on gut health?
To conduct the study, volunteers will be provided with the three different products to consume over a specified period. Their faecal samples will be collected at various points to assess changes in gut microbiota composition and other indicators of gut health. This will involve close monitoring of participants' health and adherence to ethical guidelines to ensure their safety and well-being throughout the study.
Overall, this project seeks to expand our understanding of the potential health benefits of cellobiose and other prebiotic carbohydrates. It aims to provide valuable insights into the role of these substances in promoting gut health.
Detailed description
In this randomised, double-blinded, parallel-group trial, the investigators will enroll 36 healthy adult volunteers and randomise them 1:1:1 to one of three dietary-supplement arms. Participants will consume their assigned product once daily-5 g during a one-week adaptation phase followed by 10 g/day for a three-week intervention phase. Faecal samples will be collected at baseline (Visit 1) and at study completion (Visit 5). Total bacterial counts will be determined by fluorescence in situ hybridisation coupled with flow cytometry (FISH-FLOW), and short-chain fatty acid concentrations quantified by gas chromatography-flame ionisation detection (GC-FID).
The primary outcomes are the change from baseline to Visit 5 in (1) absolute abundance of Bifidobacterium spp. and Lactobacillus spp., and (2) total faecal short-chain fatty acid concentration. Secondary outcomes include gut microbiota diversity metrics (α- and β-diversity) and daily gastrointestinal symptom incidence. Exploratory outcomes will assess correlations between shifts in specific bacterial taxa and metabolite profiles, as well as changes in the abundance of other key genera.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)Participants receive 5 g/day for the first 7 days and 10 g/day maltodextrin for the rest of the 21 days as a non-prebiotic control. |
| Orafti P95 (oligofructose P95) | Active comparator | Dietary Supplement: Oligofructose P95Healthy adult volunteers will consume 5 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the first 7 days, and consume 10 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the rest of the 21 days. |
| Cellobiose | Experimental | Dietary Supplement: CellobioseParticipants receive 5g/day for the first 7 days and 10 g/day cellobiose for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 years old and above
- Participants are willing to comply with the study instructions
- Participants have a stool frequency of at least 3 bowel movements per week
- Participants are healthy at the time of signing the consent form
Key exclusion criteria (6 listed)
- Not pregnant or planning to be pregnant
- Previously or currently diagnosed gastrointestinal diseases and disorders that might affect the gut environment.
- Food allergies or intolerances
- Previously or currently diagnosed with cancer or taking a long-term medication.
- Use of medication (e.g, antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
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 |
|---|---|---|
| CellobioseCellobiose powder (Savanna Ingredients GmbH), 5 g per day and 10 g per day, mixed into ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days. | Dietary supplement | Cellobiose |
| Oligofructose P95Oligofructose (Orafti® P95, Beneo GmbH), 5 g per day and 10 g per day, dissolved in ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days. | Dietary supplement | Orafti P95 (oligofructose P95) |
| Maltodextrin (Placebo)Maltodextrin powder (Special Ingredients Limited), 5 g per day and 10 g per day, dissolved in ~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days. | Dietary supplement | Maltodextrin |
Primary outcome
Change in absolute abundance of faecal Bifidobacterium spp. and Lactobacillus spp.
Time frame: Baseline (Day 0; Visit 1) to end of the intervention period (Day 28; Visit 5)
Absolute abundance of Bifidobacterium spp. and Lactobacillus spp. in faecal microbiota, determined by 16S rRNA gene sequencing (Illumina NGS sequencing) and FLOW-FISH for total bacterial counts
Change in total faecal short-chain fatty acid concentration
Time frame: Baseline (Day 0; Visit 1) to end of the intervention(Day 28; Visit 5)
Sum of acetate, propionate, and butyrate concentrations in faecal samples, measured by GC-MS.
2 secondary outcomes
Magnitude and pattern of overall gut-microbiota shifts from V1 to V5
Time frame: Baseline (V1) through end-point (V5) of the 28-day intervention
Number of participants with Gastrointestinal Tolerability & Safety
Time frame: Days 1 through 28 of the intervention period
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 31 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcomes (microbiome absolute counts, SCFA concentrations, GI symptom diaries), along with the study protocol and statistical analysis plan, will be made available to qualified researchers beginning six months after publication. Requests can be submitted to the corresponding author (r.a.rastall@reading.ac.uk) and will require a signed data-use agreement. Data will be shared in CSV format.
Related trials for Gut -Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
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.
Bob Rastall principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellobiose and Oligofructose P95 in people with Gut -Microbiota and As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not, run by Manxi Huang at 1 site in United Kingdom.
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 4 inclusion and 6 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 31 Jul 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 Kingdom. 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?
Change in absolute abundance of faecal Bifidobacterium spp. and Lactobacillus spp. (time frame: Baseline (Day 0; Visit 1) to end of the intervention period (Day 28; Visit 5)). The study lists 2 primary outcomes in all. 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 31 Jul 2025.