GiardiasisNCT00607074
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
A study testing Anti-Giardia and antihelmintic treatment (secnidazole or albendazole) and Anti-Giardia treatment only (secnidazole or albendazole) in people with Giardiasis, run by University of Cambridge at 1 site in Bangladesh.
Trial summary
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants. Read more about this study
- Who is it for?
- Ages 3 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Giardiasis
- What is being tested?
- Anti-Giardia and antihelmintic treatment (secnidazole or albendazole) and Anti-Giardia treatment only (secnidazole or albendazole)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteBangladesh
- Study dates
- Jun 2003to Dec 2006
- 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 3 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants living in the study area
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
National Institute of Preventive and Social Medicine
Mohakhali, Dhaka Division, 1212
About this study
Official title: Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.
Read the detailed description
A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.
- Conditions
- Giardiasis
- Being tested
- Anti-Giardia and antihelmintic treatment (secnidazole or albendazole), Anti-Giardia treatment only (secnidazole or albendazole), Control group (placebo)
- Medical subject headings
- Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)Drug
Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)
Anti-Giardia treatment only (secnidazole or albendazole)Drug
Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole
Control group (placebo)Drug
Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole); Drug: Anti-Giardia treatment only (secnidazole or albendazole); Drug: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status
Measured: 9 months
Secondary outcomes (1)
intestinal permeability
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJun 2003
- Primary completionApr 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GiardiasisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Investigators
- Nicholas C Mascie-Taylor, ScD, Study chair, Department of Biological Anthropology, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607074
- Sponsor's protocol ID
- BMRC/ERC/2001-2004/2281
- Other IDs
- BMRC/ERC/2001-2004/2281
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 5 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Goto R, Mascie-Taylor CG, Lunn PG. Impact of anti-Giardia and anthelminthic treatment on infant growth and intestinal permeability in rural Bangladesh: a randomised double-blind controlled study. Trans R Soc Trop Med Hyg. 2009 May;103(5):520-9. doi: 10.1016/j.trstmh.2008.07.020. Epub 2008 Sep 11.
PubMed 18789466
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT00607074
- Acronym / sponsor ID
- BMRC/ERC/2001-2004/2281
- Conditions
- Giardiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Feb 2008 (estimated)
- 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.
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.
Detailed description
A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole), Drug: Anti-Giardia treatment only (secnidazole or albendazole), Drug: Control group (placebo) |
Who may qualify
- Ages
- 3 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants living in the study area
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg) | Drug | 1 |
| Anti-Giardia treatment only (secnidazole or albendazole)Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole | Drug | 1 |
| Control group (placebo)Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo | Drug | 1 |
Primary outcome
nutritional status
Time frame: 9 months
1 secondary outcome
intestinal permeability
Time frame: 9 months
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 5 Feb 2008.
- Derived from this study: PubMed 18789466Goto R, Mascie-Taylor CG, Lunn PG. Impact of anti-Giardia and anthelminthic treatment on infant growth and intestinal permeability in rural Bangladesh: a randomised double-blind controlled study. Trans R Soc Trop Med Hyg. 2009 May;103(5):520-9. doi: 10.1016/j.trstmh.2008.07.020. Epub 2008 Sep 11.
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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.
Nicholas C Mascie-Taylor, ScD study chair
Department of Biological Anthropology, University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Giardia and antihelmintic treatment (secnidazole or albendazole) and Anti-Giardia treatment only (secnidazole or albendazole) in people with Giardiasis, run by University of Cambridge at 1 site in Bangladesh.
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 1 inclusion and 0 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 5 Feb 2008. 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. 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?
nutritional status (time frame: 9 months). 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 NCT00607074, which also lists 1 linked publication.
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 5 Feb 2008.