Gastrointestinal MicrobiomeNCT02867605

Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health

A study testing Hyaluronan in people with Gastrointestinal Microbiome, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Gastrointestinal Microbiome
What is being tested?: Hyaluronan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jul 2016to 20 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

BMI 19-25 (lean), and BMI 30-35 (obese)
Age 18-45 years old
Willingness to take oral supplement and adhere to study requirements

Who cannot join

Diabetes
Oral antibiotics within 4 weeks of study initiation
History of cardiac disease, and medications for cardiac disease
Use statins and antihypertensive drugs
Inflammatory bowel disease including irritable bowel syndrome
History of intestinal surgery, excluding hernia repair and appendectomy

Show all 13Show fewer

Active cancer diagnosis (except skin cancer)
Chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
Immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
Vegetarian or vegan diet7
Abnormal liver or kidney function as measured by routine serum chemistry testing
Severe anemia or significant white blood cell or platelet abnormalities
No additional blood or blood product donations during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Other trials in United States

About this study

Conditions: Gastrointestinal Microbiome
Being tested: Hyaluronan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HyaluronanDietary supplement

Study groups in NCT02867605
Study group	Role	What they receive
Healthy Controls ages 18-45 with BMI of 19-25 or 30-35	Other	Single Arm study Receives: Dietary Supplement: Hyaluronan

What is being measured

The primary outcome is the main question the study is designed to answer.

Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes
Measured: Baseline, Day 8, Day 28
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Measured: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
Measured: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration. It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions. A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates
Measured: Baseline, Day 8, Day 28
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
Measured: Baseline, Day 8, Day 28
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
Measured: Baseline, Day 8, Day 28
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Measured: Baseline, Day 8, Day 28
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
Measured: Baseline, Day 8, Day 28
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
Measured: Baseline, Day 8, Day 28
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Measured: Baseline, day 8 day 28
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
Measured: baseline, day 8, and day 28
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
Measured: baseline, day 8, and day 28
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Measured: baseline, day 8, and day 28
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Measured: Baseline, day 8, and day 28
Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.
Measured: Baseline, day 8, and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201620 Jun 2019

First posted16 Aug 2016 (estimated)
Study startJul 2016
Primary completion20 Sep 2017
Study completion20 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02867605
Sponsor's protocol ID: 16-142
Status last verified: Aug 2020
First submitted: 9 Aug 2016
Last updated: 3 Sep 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human beta-defensin 2 in intestinal epithelium. J Biol Chem. 2012 Aug 31;287(36):30610-24. doi: 10.1074/jbc.M112.356238. Epub 2012 Jul 3.
PubMed 22761444
Hill DR, Rho HK, Kessler SP, Amin R, Homer CR, McDonald C, Cowman MK, de la Motte CA. Human milk hyaluronan enhances innate defense of the intestinal epithelium. J Biol Chem. 2013 Oct 4;288(40):29090-104. doi: 10.1074/jbc.M113.468629. Epub 2013 Aug 15.
PubMed 23950179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Pilot Study - HA35 (Hyaluronan Molecular Weight 35) Dietary Supplement for Promoting Intestinal Health
ClinicalTrials.gov ID: NCT02867605
Acronym / sponsor ID: 16-142
Conditions: Gastrointestinal Microbiome
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Jul 2016 (actual)
Primary completion: 20 Sep 2017 (actual)
Study completion: 20 Jun 2019 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 13 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy Controls ages 18-45 with BMI of 19-25 or 30-35	Other	Dietary Supplement: HyaluronanSingle Arm study

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

BMI 19-25 (lean), and BMI 30-35 (obese)
Age 18-45 years old
Willingness to take oral supplement and adhere to study requirements

Key exclusion criteria (13 listed)

Diabetes
Oral antibiotics within 4 weeks of study initiation
History of cardiac disease, and medications for cardiac disease
Use statins and antihypertensive drugs
Inflammatory bowel disease including irritable bowel syndrome

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
Hyaluronan	Dietary supplement	Healthy Controls ages 18-45 with BMI of 19-25 or 30-35

Primary outcome

Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days
Time frame: Baseline, Day 8, Day 28
Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. As an example a relative abundance of firmicutes equal to 0.9 would mean that 90% of the bacteria identified in a sample are firmicutes
Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine
Time frame: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide
Time frame: Baseline, Day 8, Day 28
Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ
Time frame: Baseline, Day 8, Day 28
The respiratory quotient is a ratio between the volume of carbon dioxide exhaled and the volume of oxygen inhaled during respiration. It typically ranges between 0.7 and 1.0 and is an indicator of metabolic fuel or substrate use in tissues; it must be calculated under resting or steady-state exercise conditions. A ratio of 0.7 is indicative of mixed fat use, whereas a ratio of 1.0 indicates the exclusive use of carbohydrates
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Total Protein
Time frame: Baseline, Day 8, Day 28
Fecal Intestinal Antimicrobial Peptide Secretion at 0 Days, 8 Days and 28 Days Normalized Calprotectin and Human Beta-Defensin2
Time frame: Baseline, Day 8, Day 28
Serum Indicators of Intestinal Permeability at 0 Days, 8 Days and 28 Days Serum Lipopolysaccharide, Hyaluronan
Time frame: Baseline, Day 8, Day 28
Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-tumor Necrosis Factor (TNF) Alpha, Interleukin 6 (IL-6)
Time frame: Baseline, Day 8, Day 28
Baseline Serum Indicators of Inflammation and Injury at Baseline, 8 Days and 28 Days-C-reactive Protein
Time frame: Baseline, Day 8, Day 28
Blood Protein, Hemoglobin and Albumin Levels at Baseline, Day 8, and Day 28
Time frame: Baseline, day 8 day 28
White Blood Cell and Platelet Count at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
Alkaline Phosphatase, Alanine Transaminase , and Aspartate Transaminase at Baseline, Day 8, and Day 28
Time frame: baseline, day 8, and day 28
Serum Sodium, Potassium, and Carbon Dioxide at Baseline Day 8 and Day 28
Time frame: baseline, day 8, and day 28
Resting Energy Expenditure (REE) and Metabolic Rate at Baseline Day 8 an Day 28
Time frame: Baseline, day 8, and day 28
Resting Energy Expenditure as a Percent of Predicted at Baseline, Day 8, and Day 28
Time frame: Baseline, day 8, and day 28
This values measures the amount of energy a person uses during rest and compares it the average expected number of someone who is the same gender, age, and race.

Results and safety

Results posted to the registry on 13 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Controls Ages 18-45 With BMI of 19-25 or 30-35	20	20

Primary outcome: Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days

Time frame: Baseline, Day 8, Day 28. Mean (Standard Deviation). Unit: ratio

Measure	Day 0 n = 20	Day 8 n = 20	Day 28 n = 20
firmicutes	0.697 (0.164)	0.722 (0.133)	0.735 (0.118)
actinobacteria	0.146 (0.0985)	0.145 (0.111)	0.141 (0.0951)
bacteroidetes	0.0969 (0.0855)	0.00789 (0.0497)	0.101 (0.102)
verrucomicrobia	0.0415 (0.117)	0.0398 (0.115)	0.0151 (0.0273)
proteobacteria	0.0111 (0.0211)	0.00789 (0.0118)	0.00432 (0.00509)
euryarchaeota	0.00381 (0.00797)	0.00295 (0.00558)	0.00221 (0.00463)
tenericutes	0.00275 (0.00605)	0.00267 (0.00602)	0.00152 (0.00322)
unclassified	0.000272 (0.00000633)	0.000243 (0.00000618)	0.000237 (0.00000733)

Primary outcome: Laboratory Parameters at Day 0, Day 8 and 28 Calcium, Bilirubin, Glucose, Blood Urea Nitrogen, Creatinine

Time frame: Baseline, Day 8, Day 28. Mean (Standard Deviation). Unit: mg/dL

Measure	Day 0 n = 20	Day 8 n = 20	Day 28 n = 20
Calcium	9.2 (0.4)	9.2 (0.2)	9.1 (0.3)
Bilirubin (total)	0.4 (0.3)	0.4 (0.2)	0.4 (0.3)
Glucose	92 (20)	94 (16)	89 (27)
blood urea nitrogen	11 (3)	11 (4)	12 (3)
Creatinine	0.85 (0.16)	0.85 (0.16)	0.83 (0.15)

Primary outcome: Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Volume of Oxygen and Volume Carbon Dioxide

Time frame: Baseline, Day 8, Day 28. Mean (Standard Deviation). Unit: L/min

Measure	Day 0 n = 20	Day 8 n = 20	Day 28 n = 20
volume oxygen	0.225 (0.041)	0.224 (0.039)	0.239 (0.048)
volume carbon dioxide	0.180 (0.029)	0.184 (0.035)	0.197 (0.038)

Primary outcome: Indirect Calorimetry Data at 0 Day, 8 Days and 28 Days Respiratory Quotient RQ

Time frame: Baseline, Day 8, Day 28. Mean (Standard Deviation). Unit: ratio

Measure	Day 0 n = 20	Day 8 n = 20	Day 28 n = 20
Value	0.808 (0.077)	0.822 (0.061)	0.826 (0.0708)

Adverse events

Time frame: 0-28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Day 0	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Day 8	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Day 28	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22761444Hill DR, Kessler SP, Rho HK, Cowman MK, de la Motte CA. Specific-sized hyaluronan fragments promote expression of human beta-defensin 2 in intestinal epithelium. J Biol Chem. 2012 Aug 31;287(36):30610-24. doi: 10.1074/jbc.M112.356238. Epub 2012 Jul 3.
Background: PubMed 23950179Hill DR, Rho HK, Kessler SP, Amin R, Homer CR, McDonald C, Cowman MK, de la Motte CA. Human milk hyaluronan enhances innate defense of the intestinal epithelium. J Biol Chem. 2013 Oct 4;288(40):29090-104. doi: 10.1074/jbc.M113.468629. Epub 2013 Aug 15.

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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.

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 Hyaluronan in people with Gastrointestinal Microbiome, run by The Cleveland Clinic 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 3 inclusion and 13 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 3 Sep 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 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. 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?

Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Composition of Stool Micro Biome Diversity and Phylogenetic Distribution at 0 Days, 8 Days and 28 Days (time frame: Baseline, Day 8, Day 28). The study lists 15 primary outcomes in all. 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 NCT02867605, which also lists 2 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 3 Sep 2020.