Functional ConstipationNCT03462199

Evaluating Efficacy of Investigational Products on Spontaneous Bowel Movements in Healthy People With ≤ 3 Complete Weekly Spontaneous Bowel Movements

A study testing Actazin (green kiwi powder) High Dose, Actazin (green kiwi powder) Low Dose and Livaux (gold kiwi powder) High Dose in people with Functional Constipation and Healthy, run by AIDP, Inc. at 1 site in Canada.

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Functional Constipation, Healthy
What is being tested?: Actazin (green kiwi powder) High Dose, Actazin (green kiwi powder) Low Dose and Livaux (gold kiwi powder) High Dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteCanada
Study dates: 23 Mar 2018to 3 Feb 2020
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females 18 to 60 years of age, inclusive at baseline
Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All birth control must have been in use for a minimum of three months and the participant must have one regular menstrual cycle in the last 30 days. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices

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Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner (shown successful as per appropriate follow-up)
Body mass index (BMI) between 19 and 29.9 ±1 kg/m2 at screening, inclusive
Participants must have the following criteria based on participant self-reporting:
Self-reported ≤ 3 CSBMs per week at screening and confirmed in the BHD during the run-in period for enrolment at baseline
People who are not regular consumers of, high fibre diets, yoghurt, fermented foods such as kimchi, kombucha, sauerkraut etc.
Fasting blood glucose ≤6.0 mmol/L at screening
Agree to refrain from the consumption high-fiber dietary supplements including Metamucil, Benefibre, and Phloe
Agree to refrain from the consumption of fresh kiwifruit 2-weeks prior to and during the study
Agree to maintain their habitual food and beverage intakes
Agree to maintain current physical activity patterns
Agree to avoid overseas travel for the duration of the study due to the impact this may have on diet and gastrointestinal health
Healthy as determined by laboratory results, medical history, and physical exam as assessed by the Qualified Investigator
Willingness to complete questionnaires, records, and diaries associated with the study, collect stool samples, and to complete all clinic visits
Has given voluntary, written, informed consent to participate in the study

Who cannot join

Women who are pregnant, breast feeding, or planning to become pregnant during the trial
Participation in a clinical research trial within 30 days prior to randomization
Blood donation during the study or within 30 days of completing the study
Vegan, raw food, or very high-fiber diet, including regular consumption of foods labeled as supplemented with fiber.
Weight loss of >5% within the past 3 months
Frequent use of laxatives defined as greater than once per week.

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Use of medications such as antibiotics that have major impact on gut microbes 2 months prior to baseline and as assessed case by case by the QI
Use of probiotic and prebiotic dietary supplements.
Regular intake of nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or other anti-inflammatory medications
Use of medications for constipation and or Diarrhea as assessed by QI
Allergy or sensitivity to kiwifruit or other test product ingredients
Prior surgery for weight loss (lap band or gastric bypass)
Gastrointestinal alarm symptoms including blood in stools, frequent diarrhea, and unremitting abdominal pain, and major diseases of the gastrointestinal tract (such as IBS, Crohn's, etc.), pulmonary or endocrine systems, or other GI abnormalities
Gastroparesis or lactose intolerance
Current, or history of, thyroid disease
Uncontrolled hypertension (SBP ≥160 mmHg) assessed by QI
Renal, hepatic, pancreatic, or biliary impairment or disease as disclosed or detected (if applicable) by chemistry and hematology taken at screening
Current, or history of, bleeding/blood disorders
Type I and Type II diabetes
Autoimmune disease or immuno-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis will be considered as per the QI's opinion
Clinically significant abnormal laboratory results at screening
Alcohol or drug abuse within the last 6 months
Participants with a history of cigarette smoking within the past 5 years.
Individuals who are cognitively impaired and/or who are unable to give informed consent
Any other condition which in the qualified investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant

Trial locations and contacts

1 site in 1 country.

Canada1 site

KGK Clinical Trial Centers
London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of the Investigational Products on Complete Spontaneous Bowel Movements in Participants Who Normally Have ≤ 3 Complete Spontaneous Bowel Movements Per Week But Are Otherwise Healthy

Low and High doses of Actazin and Livaux will be compared against a control formula and placebo to evaluate how each investigational study product effects complete spontaneous bowel movements in healthy adults that currently experience less than or equal to 3 complete spontaneous bowel movements per week. During the 28-day study period, it is hypothesized that participants consuming Acatzin, Livaux, or control formula will have an increased number of complete spontaneous bowel movements when compared to participants consuming the placebo. It is hypothesized that participants consuming Actazin or Livaux will respond more than participants consuming the control formula. It is hypothesized that participants consuming Actazin or Livaux will have a favorable microbiome change than placebo.

Conditions: Functional Constipation, Healthy
Being tested: Actazin (green kiwi powder) High Dose, Actazin (green kiwi powder) Low Dose, Control Formula (Actazin green kiwi powder + PreticX prebiotic), Livaux (gold kiwi powder) High Dose, Livaux (gold kiwi powder) Low Dose
Keywords: Kiwi, Constipation, Bowel Movements, Healthy, Functional Constipation
Medical subject headings: Constipation

What participants receive

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

Actazin (green kiwi powder) High DoseDietary supplement
Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days
Actazin (green kiwi powder) Low DoseDietary supplement
Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days
Control Formula (Actazin green kiwi powder + PreticX prebiotic)Dietary supplement
Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days
Livaux (gold kiwi powder) High DoseDietary supplement
Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days
Livaux (gold kiwi powder) Low DoseDietary supplement
Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days
Placebo (microcrystalline cellulose)Dietary supplement
Participants will consume 4 capsules containing no active ingredients daily for 28-days

Study groups in NCT03462199
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Dietary Supplement: Placebo (microcrystalline cellulose)
Actazin High Dose	Experimental	Not described Receives: Dietary Supplement: Actazin (green kiwi powder) High Dose
Actazin Low Dose	Experimental	Not described Receives: Dietary Supplement: Actazin (green kiwi powder) Low Dose
Control Formula	Active comparator	Not described Receives: Dietary Supplement: Control Formula (Actazin green kiwi powder + PreticX prebiotic)
Livaux High Dose	Experimental	Not described Receives: Dietary Supplement: Livaux (gold kiwi powder) High Dose
Livaux Low Dose	Experimental	Not described Receives: Dietary Supplement: Livaux (gold kiwi powder) Low Dose

What is being measured

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

The change in complete spontaneous bowel movements between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and Placebo
Assessed by the daily bowel habits diary. A complete spontaneous bowel movements is defined as bowel movements that are both complete and spontaneous.
Measured: 28 days

Secondary outcomes (10)

The change in spontaneous bowel movements per week between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed using the daily bowel habits diary
Measured: 28 days
The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the Brstiol Stool Scale (BSS). BSS scores are a measure of stool form. It is on a scale of 1-7, 1 = highly constipated; 7 = diarrhea. A score of type 3-4 are considered normal and movement towards these scores are indicative of healthier bowel functions.
Measured: 28 days
The change in interval between bowel movements in hours between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed using the daily bowel habits diary
Measured: 28 days
The change in blood calcium levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fasting blood sample analysis
Measured: 28 days
The change in fasting glucose levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fasting blood sample analysis
Measured: 28 days
The change in the Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the participants answers to the PAC-SYM questions which assess the severity of patient-reported symptoms of constipation. It is ona scale of 0-4 ( 0= symptoms absent and 4 = severe symptoms.
Measured: 28 days
The change in the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the participants answers to the PAC-QoL questions. Effect on quality of life is measured on a scale of 0 - 4 (0= no effect on quality of life, and 4 = negative effect on quality of life
Measured: 28 days
The change in gut microbiome between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by fecal sample analysis
Measured: 28 days
The percentage of early and late responders to Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the bowel habits diary
Measured: 28 days
The difference in the Bowel Regularity Index Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Assessed by the Bowel Regularity Index questionnaire in which participants were provided with a series of twelve statements and asked to score each. Scoring for this index is based on a five-point scale for each question, from strongly disagree (0) to strongly agree (5).
Measured: 28 days

Timeline

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

23 Mar 20183 Feb 2020

First posted12 Mar 2018
Study start23 Mar 2018
Primary completion1 Feb 2020
Study completion3 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Functional ConstipationStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized, double-blind, placebo controlled, parallel study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03462199
Sponsor's protocol ID: 18ACHA
Status last verified: Jul 2019
First submitted: 6 Mar 2018
Last updated: 14 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease

All Functional Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of the Investigational Products on Complete Spontaneous Bowel Movements in Participants Who Normally Have ≤ 3 Complete Spontaneous Bowel Movements Per Week But Are Otherwise Healthy
ClinicalTrials.gov ID: NCT03462199
Acronym / sponsor ID: 18ACHA
Conditions: Functional Constipation, Healthy
Keywords: Kiwi, Constipation, Bowel Movements, Healthy, Functional Constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: AIDP, Inc.Industry (pharma, biotech, devices)
Collaborators: KGK Science Inc.
Study start: 23 Mar 2018 (actual)
Primary completion: 1 Feb 2020 (actual)
Study completion: 3 Feb 2020 (actual)
First posted: 12 Mar 2018 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: randomized, double-blind, placebo controlled, parallel study

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: Placebo (microcrystalline cellulose)
Actazin High Dose	Experimental	Dietary Supplement: Actazin (green kiwi powder) High Dose
Actazin Low Dose	Experimental	Dietary Supplement: Actazin (green kiwi powder) Low Dose
Control Formula	Active comparator	Dietary Supplement: Control Formula (Actazin green kiwi powder + PreticX prebiotic)
Livaux High Dose	Experimental	Dietary Supplement: Livaux (gold kiwi powder) High Dose
Livaux Low Dose	Experimental	Dietary Supplement: Livaux (gold kiwi powder) Low Dose

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (21 listed)

Males and females 18 to 60 years of age, inclusive at baseline
Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All birth control must have been in use for a minimum of three months and the participant must have one regular menstrual cycle in the last 30 days. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method

Key exclusion criteria (26 listed)

Women who are pregnant, breast feeding, or planning to become pregnant during the trial
Participation in a clinical research trial within 30 days prior to randomization
Blood donation during the study or within 30 days of completing the study
Vegan, raw food, or very high-fiber diet, including regular consumption of foods labeled as supplemented with fiber.
Weight loss of >5% within the past 3 months

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
Actazin (green kiwi powder) High DoseParticipants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days	Dietary supplement	Actazin High Dose
Actazin (green kiwi powder) Low DoseParticipants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days	Dietary supplement	Actazin Low Dose
Control Formula (Actazin green kiwi powder + PreticX prebiotic)Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days	Dietary supplement	Control Formula
Livaux (gold kiwi powder) High DoseParticipants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days	Dietary supplement	Livaux High Dose
Livaux (gold kiwi powder) Low DoseParticipants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days	Dietary supplement	Livaux Low Dose
Placebo (microcrystalline cellulose)Participants will consume 4 capsules containing no active ingredients daily for 28-days	Dietary supplement	Placebo

Primary outcome

The change in complete spontaneous bowel movements between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and Placebo
Time frame: 28 days
Assessed by the daily bowel habits diary. A complete spontaneous bowel movements is defined as bowel movements that are both complete and spontaneous.

10 secondary outcomes

The change in spontaneous bowel movements per week between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in stool form between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in interval between bowel movements in hours between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in blood calcium levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in fasting glucose levels between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in the Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The change in gut microbiome between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The percentage of early and late responders to Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days
The difference in the Bowel Regularity Index Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and placebo.
Time frame: 28 days

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 14 Jul 2020.
Individual participant dataSharing planned: Undecided

Related trials for Functional Constipation

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease

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.

David Crowley, MD principal investigator

KGK Science Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 26 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 14 Jul 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 Canada. 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?

The change in complete spontaneous bowel movements between Actazin High Dose, Actazin Low Dose, Livaux High Dose, Livaux Low Dose, Control Formula, and Placebo (time frame: 28 days). 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 NCT03462199.

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 14 Jul 2020.