DiarrheaNCT03406793

Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth

A study testing Standard MNP, High zinc, low iron MNP and High zinc, low/no iron on alternating days in people with Diarrhea and Stunting, run by UCSF Benioff Children's Hospital Oakland at 1 site in Bangladesh.

Completed

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

Official record

Search all trials

Trial summary

This is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in Dhaka, Bangladesh. Read more about this study

Who is it for?: Ages 9 to 11 monthsHealthy volunteers can take part
Conditions the study is for: Diarrhea, Stunting
What is being tested?: Standard MNP, High zinc, low iron MNP and High zinc, low/no iron on alternating days
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,886 participants
Where: 1 siteBangladesh
Study dates: 20 Feb 2018to 12 Jan 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 9 to 11 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

9-11 months of age
Weight-for-length Z score >= -3 according to the 2006 World Health Organization Growth Standards
Hemoglobin concentration > = 7.0 g/dL

Who cannot join

Presence of severe acute malnutrition, defined as a WLZ <-3 and/or the presence of bipedal edema and/or mid-upper arm circumference <115 mm;
Presence of severe anemia, defined as a hemoglobin concentration < 7.0 g/dL
Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
Currently consuming MNPs with no intention of stopping

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Icddr,B
Dhaka

Other trials in Bangladesh

About this study

Official title: Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children

Read the detailed description

Zinc is essential to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9-11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh's national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention.

Conditions: Diarrhea, Stunting
Being tested: Standard MNP, High zinc, low iron MNP, High zinc, low/no iron on alternating days, Dispersible zinc supplement, Intermittent zinc supplement
Keywords: Zinc, Multiple micronutrient powders, Diarrhea, Stunting
Medical subject headings: Diarrhea, Growth Disorders

What participants receive

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

Standard MNPDietary supplement
Standard MNP, 15 micronutrients (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg). Daily supplementation for 24 weeks.
High zinc, low iron MNPDietary supplement
Same as group 1, except with 10 mg zinc instead of 4.1 mg and 6 mg iron instead of 10 mg. Daily supplementation for 24 weeks.
High zinc, low/no iron on alternating daysDietary supplement
Same as study group 1, except with 10 mg zinc instead of 4.1 mg, and 6 mg iron and no iron on alternating days instead of 10 mg. Daily supplementation for 24 weeks.
Dispersible zinc supplementDietary supplement
10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.
Intermittent zinc supplementDietary supplement
10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.
Placebo powderDietary supplement
Daily provision of a placebo powder for 24 weeks.

Study groups in NCT03406793
Study group	Role	What they receive
1. Standard MNP	Experimental	Not described Receives: Dietary Supplement: Standard MNP
2. High zinc, low iron MNP	Experimental	Not described Receives: Dietary Supplement: High zinc, low iron MNP
3. High zinc, low/no iron	Experimental	Not described Receives: Dietary Supplement: High zinc, low/no iron on alternating days
4. Dispersible zinc supplement	Active comparator	Not described Receives: Dietary Supplement: Dispersible zinc supplement
5. Intermittent zinc supplement	Experimental	Not described Receives: Dietary Supplement: Intermittent zinc supplement
6. Placebo powder	Placebo comparator	Not described Receives: Dietary Supplement: Placebo powder

What is being measured

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

Incidence of diarrhea
Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up
Measured: Incidence over the 24-week follow-up period
Change in length-for-age Z score
Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period
Measured: Measured at enrollment and the end of the 24-week follow-up period

Secondary outcomes (17)

Change in stunting prevalence
Change in the prevalence of stunting (LAZ <-2) in the study population over the 24-week follow-up period
Measured: Measured at enrollment and the end of the 24-week follow-up period
Change in wasting prevalence
Change in the prevalence of wasting (WLZ <-2) in the study population over the 24-week follow-up period
Measured: Measured at enrollment and at the end of the 24-week follow-up period
Incidence of dysentery
Dysentery is defined as any diarrheal episode in which the loose or watery stools contain visible red blood
Measured: Measured twice weekly for 24 weeks
Incidence of diarrhea with dehydration
Incidence of diarrhea with dehydration over the 24-week follow-up period
Measured: Measured twice weekly for 24 weeks
Incidence of hospitalizations
Hospitalization is defined as an overnight stay in the hospital due to illness
Measured: Assessed twice weekly for 24 weeks
Change in mean serum zinc concentration
Change in mean serum zinc concentration among children in the biochemistry sub-group over the 24-week follow-up period
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in the prevalence of zinc deficiency
Change in the prevalence of zinc deficiency (serum zinc concentration <9.9 umol/L) in the biochemistry subgroup from baseline to the end of the 24-week follow-up period
Measured: Measured at enrollment and at the end of the 24-week follow-up period in subgroup of participants in all 6 intervention groups
Change in the exchangeable zinc pool size
Change in the exchangeable zinc pool size from enrollment to the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP group, dispersible zinc supplement group, and placebo group
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in ferritin concentrations
Change in mean concentrations of ferritin from enrollment to the end of the 24-week follow-up period among participants in the biochemistry subgroup.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in concentrations of soluble transferrin receptor
Change in mean concentrations of soluble transferrin receptor from enrollment to the end of the 24-week follow-up period among participants in the biochemistry subgroup.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in gut microbiota
Change in the composition of gut microbiota from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron; dispersible zinc supplement; and placebo powder groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in amino acid metabolites associated with gut permeability
To compare the change in amino acid metabolites associated with gut permeability from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in lipid metabolites associated with gut permeability
To compare the change in lipid metabolites associated with gut permeability from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in genome wide gene expression by RNA-sequencing
To compare the change in genome wide gene expression, measured with RNA-sequencing, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in specific gene expression by quantitative Polymerase Chain Reaction
To compare the change in specific gene expression, measured by quantitative Polymerase Chain Reaction, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in cellular immune function by leukocyte profiles
To compare the change in cellular immune function by leukocyte profiles, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in serum cytokines
To compare the change in serum cytokines, measured by Luminex analysis, from enrollment to the end of the 24-week follow-up period among a subgroup of participants randomized to the high zinc, low-iron MNP; dispersible zinc supplement; and placebo groups.
Measured: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

Timeline

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

20 Feb 201812 Jan 2020

First posted23 Jan 2018
Study start20 Feb 2018
Primary completion12 Jan 2020
Study completion12 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiarrheaStudies 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,886 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03406793
Sponsor's protocol ID: 1.05
Status last verified: Oct 2020
First submitted: 12 Jan 2018
Last updated: 3 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Thompson L, Arnold C, Peerson J, Long JM, Westcott JLE, Islam MM, Black RE, Krebs NF, McDonald CM. Predictors of Anaemia Among Young Children Receiving Daily Micronutrient Powders (MNPs) for 24 Weeks in Bangladesh: A Secondary Analysis of the Zinc in Powders Trial. Matern Child Nutr. 2025 Jul;21(3):e13806. doi: 10.1111/mcn.13806. Epub 2025 Feb 10.
PubMed 39925177
Islam MM, Black RE, Krebs NF, Westcott J, Long J, Islam KM, Peerson JM, Sthity RA, Khandaker AM, Hasan M, El Arifeen S, Ahmed T, King JC, McDonald CM. Different Doses, Forms, and Frequencies of Zinc Supplementation for the Prevention of Diarrhea and Promotion of Linear Growth among Young Bangladeshi Children: A Six-Arm, Randomized, Community-Based Efficacy Trial. J Nutr. 2022 May 5;152(5):1306-1315. doi: 10.1093/jn/nxab439.
PubMed 35015856

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

Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea

All Diarrhea trials

Study at a glance

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

Official title: Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children
ClinicalTrials.gov ID: NCT03406793
Acronym / sponsor ID: 1.05
Conditions: Diarrhea, Stunting
Keywords: Zinc, Multiple micronutrient powders, Diarrhea, Stunting
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,886 participants (actual)
Lead sponsor: UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh, Johns Hopkins Bloomberg School of Public Health, University of Colorado, Denver
Study start: 20 Feb 2018 (actual)
Primary completion: 12 Jan 2020 (actual)
Study completion: 12 Jan 2020 (actual)
First posted: 23 Jan 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
1. Standard MNP	Experimental	Dietary Supplement: Standard MNP
2. High zinc, low iron MNP	Experimental	Dietary Supplement: High zinc, low iron MNP
3. High zinc, low/no iron	Experimental	Dietary Supplement: High zinc, low/no iron on alternating days
4. Dispersible zinc supplement	Active comparator	Dietary Supplement: Dispersible zinc supplement
5. Intermittent zinc supplement	Experimental	Dietary Supplement: Intermittent zinc supplement
6. Placebo powder	Placebo comparator	Dietary Supplement: Placebo powder

Who may qualify

Ages: 9 to 11 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

9-11 months of age
Weight-for-length Z score >= -3 according to the 2006 World Health Organization Growth Standards
Hemoglobin concentration > = 7.0 g/dL

Key exclusion criteria (5 listed)

Presence of severe acute malnutrition, defined as a WLZ <-3 and/or the presence of bipedal edema and/or mid-upper arm circumference <115 mm;
Presence of severe anemia, defined as a hemoglobin concentration < 7.0 g/dL
Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
Currently consuming MNPs with no intention of stopping

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
Standard MNPStandard MNP, 15 micronutrients (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg). Daily supplementation for 24 weeks.	Dietary supplement	1. Standard MNP
High zinc, low iron MNPSame as group 1, except with 10 mg zinc instead of 4.1 mg and 6 mg iron instead of 10 mg. Daily supplementation for 24 weeks.	Dietary supplement	2. High zinc, low iron MNP
High zinc, low/no iron on alternating daysSame as study group 1, except with 10 mg zinc instead of 4.1 mg, and 6 mg iron and no iron on alternating days instead of 10 mg. Daily supplementation for 24 weeks.	Dietary supplement	3. High zinc, low/no iron
Dispersible zinc supplement10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.	Dietary supplement	4. Dispersible zinc supplement
Intermittent zinc supplement10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.	Dietary supplement	5. Intermittent zinc supplement
Placebo powderDaily provision of a placebo powder for 24 weeks.	Dietary supplement	6. Placebo powder

Primary outcome

Incidence of diarrhea
Time frame: Incidence over the 24-week follow-up period
Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up
Change in length-for-age Z score
Time frame: Measured at enrollment and the end of the 24-week follow-up period
Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period

17 secondary outcomes

Change in stunting prevalence
Time frame: Measured at enrollment and the end of the 24-week follow-up period
Change in wasting prevalence
Time frame: Measured at enrollment and at the end of the 24-week follow-up period
Incidence of dysentery
Time frame: Measured twice weekly for 24 weeks
Incidence of diarrhea with dehydration
Time frame: Measured twice weekly for 24 weeks
Incidence of hospitalizations
Time frame: Assessed twice weekly for 24 weeks
Change in mean serum zinc concentration
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in the prevalence of zinc deficiency
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in subgroup of participants in all 6 intervention groups
Change in the exchangeable zinc pool size
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in ferritin concentrations
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in concentrations of soluble transferrin receptor
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants in all 6 intervention groups
Change in gut microbiota
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in amino acid metabolites associated with gut permeability
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in lipid metabolites associated with gut permeability
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in genome wide gene expression by RNA-sequencing
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in specific gene expression by quantitative Polymerase Chain Reaction
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in cellular immune function by leukocyte profiles
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.
Change in serum cytokines
Time frame: Measured at enrollment and at the end of the 24-week follow-up period in a subgroup of participants randomized to the high zinc, low-iron MNP, dispersible zinc supplement, and placebo groups.

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 3 Nov 2020.
Derived from this study: PubMed 39925177Thompson L, Arnold C, Peerson J, Long JM, Westcott JLE, Islam MM, Black RE, Krebs NF, McDonald CM. Predictors of Anaemia Among Young Children Receiving Daily Micronutrient Powders (MNPs) for 24 Weeks in Bangladesh: A Secondary Analysis of the Zinc in Powders Trial. Matern Child Nutr. 2025 Jul;21(3):e13806. doi: 10.1111/mcn.13806. Epub 2025 Feb 10.
Derived from this study: PubMed 35015856Islam MM, Black RE, Krebs NF, Westcott J, Long J, Islam KM, Peerson JM, Sthity RA, Khandaker AM, Hasan M, El Arifeen S, Ahmed T, King JC, McDonald CM. Different Doses, Forms, and Frequencies of Zinc Supplementation for the Prevention of Diarrhea and Promotion of Linear Growth among Young Bangladeshi Children: A Six-Arm, Randomized, Community-Based Efficacy Trial. J Nutr. 2022 May 5;152(5):1306-1315. doi: 10.1093/jn/nxab439.
Individual participant dataSharing planned: No

Related trials for Diarrhea

Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea

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.

Robert Black, MD, MPH principal investigator

Johns Hopkins Bloomberg School of Public Health

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 3 inclusion and 5 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 Nov 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 Bangladesh. 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?

Incidence of diarrhea (time frame: Incidence over the 24-week follow-up period). 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?

On the ClinicalTrials.gov record for NCT03406793, 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 Nov 2020.