Gastrointestinal DysfunctionNCT05418127
An Efficacy Trial in the Research Area of Gastrointestinal Health & Bloating
A study testing Active in people with Gastrointestinal Dysfunction, run by Coconut Goodness Food Products Inc. at 1 site in United States.
Trial summary
A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults. Read more about this study
- Who is it for?
- Ages 25 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 31 Mar 2023
- 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 25 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in the study and comply with its procedures, including but not limited to consuming study product, adhering to visit schedule and e-diary/questionnaires, abstaining from products outlined in Section 5.8 of Study Protocol.
- Able and willing to give written informed consent.
- Adults aged between 25 to 54 years, inclusive.
- Self-reported bloating on at least 3 occasions over the 7-day period immediately prior to enrolment (confirmed by selecting any option other than 'None' in response to the daily electronic diary Bloating question in the electronic diary questionnaire completed prior to enrolment).
Who cannot join
- Participants who are pregnant or wish to become pregnant during the trial.
- Participants who are lactating and/or currently breastfeeding.
- Participants currently of childbearing potential, but not using an effective method of contraception for at least 30 days prior to dosing, as outlined below:
- Complete abstinence from intercourse prior to administration of the study product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
- Sexual partner(s) is/are exclusively female.
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- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), or contraceptive pill/patch/injection/ring. The participant must be using this method for at least 30 days prior to and 2 weeks following the end of the trial.
- Use of any intrauterine device (IUD) or contraceptive implant. The participant must have the device inserted at least 30 days prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
- Participants who have a history of histamine intolerance (i.e., intolerance to fermented food) or any known coconut or tree nut allergy.
- Participants who have consumed prebiotic or probiotic supplements in the 14 days prior to screening (Visit 1).
- Participants have consumed fermented coconut/kefir products in the 14 days prior to screening (Visit 1) and are intending to consume such products during the course of the trial.
- Participants who have used oral antibiotics in the 90 days prior to screening (Visit 1).
- Participants who have had gastrointestinal surgery (e.g., colectomy, gall bladder removal, gastric bypass) - appendectomy not considered an exclusionary surgery.
- Participants who have any significant health conditions or current medications that would prevent them from fulfilling the trial requirements, put the Participant at risk or would confound the interpretation of the trial results as judged by the investigator on the basis of medical history, medication history, and routine laboratory test results.
- Participants who cannot safety stop taking prescription medication for the duration of the trial
- Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to screening (Visit 1).
- Participants who have used any immunosuppressant or chemotherapy medications, including marcaptopurine, azothioprine, or methotrexate in the last 5 years.
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- Any Participant who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Clinical Trials Ltd.
Chicago, Illinois, 60611
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of Traditionally Fermented Organic Coconut Milk Kefir on Gastrointestinal Symptoms in Healthy Adults
A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Active, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
Traditionally-fermented coconut milk kefir
PlaceboOther
Solution of Calcium Carbonate and coconut extract
| Study group | Role | What they receive |
|---|---|---|
| 30 Participants receiving Placebo product. | Placebo comparator | Solution of filtered water, Calcium Carbonate powder, and coconut extract. Receives: Other: Placebo |
| 30 Participants receiving Active product. | Active comparator | Traditionally-fermented coconut milk kefir. Receives: Dietary Supplement: Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of bloating from baseline to Week 8 (confirmed by selecting a lower category of severity of bloating during the 7-day period prior to end of intervention compared to the 7-day period prior to Baseline on the day with their worst symptom rating).
Measured: 8 weeks
Secondary outcomes (4)
Change in mean daily severity of Abdominal Pain symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of abdominal pain (as recorded in the daily e-diary Abdominal Pain question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
Measured: 8 weeks
Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of abdominal discomfort (as recorded in the daily e-diary Abdominal Discomfort question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
Measured: 8 weeks
Change in proportion of Participants experiencing Flatulence/Gas symptoms (selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question).
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of flatulence/gas (confirmed by selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question) during the 7-day period prior Baseline compared to the 7-day period prior to end of intervention.
Measured: 8 weeks
Difference between product groups of self-reported symptom improvement from the Global Impression of Change Scale at end of intervention.
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on their overall perception of their bloating symptoms as reported in a product satisfaction questionnaire at week 8. Subjects rate perception of change in bloating using a visual analogue scale (VAS) rated from "There has been no change to my bloating" to "There has been a significant change to my bloating"
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start16 May 2022
- Primary completion7 Nov 2022
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies 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
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coconut Goodness Food Products Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Linda Peers, Coconut Goodness Food Products Inc.
- Investigators
- Stacey Boetto, FNP-C, Principal investigator, Atlantia Clinical Trials Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418127
- Sponsor's protocol ID
- AFCRO-151
- Status last verified
- Jan 2023
- First submitted
- 1 Jun 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Those conducting research in the area of Gastrointestinal Health \& Bloating
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of Traditionally Fermented Organic Coconut Milk Kefir on Gastrointestinal Symptoms in Healthy Adults
- ClinicalTrials.gov ID
- NCT05418127
- Acronym / sponsor ID
- AFCRO-151
- Conditions
- Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coconut Goodness Food Products Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 14 Jun 2022 (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.
A randomized, double-blinded, placebo-controlled, parallel study, to evaluate the effect of 8-week supplementation of a traditionally fermented organic coconut milk kefir compared to placebo on gastrointestinal symptoms in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study.
| Arm | Type | Receives |
|---|---|---|
| 30 Participants receiving Placebo product. | Placebo comparator | Other: PlaceboSolution of filtered water, Calcium Carbonate powder, and coconut extract. |
| 30 Participants receiving Active product. | Active comparator | Dietary Supplement: ActiveTraditionally-fermented coconut milk kefir. |
Who may qualify
- Ages
- 25 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to participate in the study and comply with its procedures, including but not limited to consuming study product, adhering to visit schedule and e-diary/questionnaires, abstaining from products outlined in Section 5.8 of Study Protocol.
- Able and willing to give written informed consent.
- Adults aged between 25 to 54 years, inclusive.
- Self-reported bloating on at least 3 occasions over the 7-day period immediately prior to enrolment (confirmed by selecting any option other than 'None' in response to the daily electronic diary Bloating question in the electronic diary questionnaire completed prior to enrolment).
Key exclusion criteria (19 listed)
- Participants who are pregnant or wish to become pregnant during the trial.
- Participants who are lactating and/or currently breastfeeding.
- Participants currently of childbearing potential, but not using an effective method of contraception for at least 30 days prior to dosing, as outlined below:
- Participants who have a history of histamine intolerance (i.e., intolerance to fermented food) or any known coconut or tree nut allergy.
- Participants who have consumed prebiotic or probiotic supplements in the 14 days prior to screening (Visit 1).
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 |
|---|---|---|
| ActiveTraditionally-fermented coconut milk kefir | Dietary supplement | 30 Participants receiving Active product. |
| PlaceboSolution of Calcium Carbonate and coconut extract | Other | 30 Participants receiving Placebo product. |
Primary outcome
Change in proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary.
Time frame: 8 weeks
To evaluate in healthy adults who experience gastrointestinal bloating or distention the effect of 8-week supplementation of a fermented coconut milk kefir compared to Placebo on the severity of bloating from baseline to Week 8 (confirmed by selecting a lower category of severity of bloating during the 7-day period prior to end of intervention compared to the 7-day period prior to Baseline on the day with their worst symptom rating).
4 secondary outcomes
Change in mean daily severity of Abdominal Pain symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
Time frame: 8 weeks
Change in mean daily severity of Abdominal Discomfort symptoms of Participants (as recorded in the daily e-diary Abdominal Pain question).
Time frame: 8 weeks
Change in proportion of Participants experiencing Flatulence/Gas symptoms (selecting any option other than 'None' in response to the daily e-diary Flatulence/Gas question).
Time frame: 8 weeks
Difference between product groups of self-reported symptom improvement from the Global Impression of Change Scale at end of intervention.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No. Those conducting research in the area of Gastrointestinal Health \& Bloating
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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.
Stacey Boetto, FNP-C principal investigator
Atlantia Clinical Trials Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Gastrointestinal Dysfunction, run by Coconut Goodness Food Products Inc. 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. 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?
Results are not available in the source record.
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 proportion of Participants who report a change in the maximum severity of their bloating in a daily eDiary. (time frame: 8 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 19 Jan 2023.