PregnancyNCT02021799
The Effect of Under-nutrition on the Human Microbiota
A study testing Moringa and Lactobacillus rhamnosus GR-1 in people with Pregnancy, run by Western University, Canada at 1 site in Tanzania.
Trial summary
The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Moringa and Lactobacillus rhamnosus GR-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2012to Apr 2013
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Greater than 12 weeks pregnant
- between the ages of 18 and 40 years
Who cannot join
- Less than 12 weeks pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.
- Conditions
- Pregnancy
- Being tested
- Moringa and Lactobacillus rhamnosus GR-1
- Keywords
- Gut microbiome, Vaginal microbiome, Oral microbiome, Human milk microbiome, Nutritional Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa and Lactobacillus rhamnosus GR-1Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Undernourished Pregnant Women | No intervention | Pregnant women who are classified as undernourished |
| Nourished Pregnant Women | No intervention | Pregnant women who are classified as healthy |
| Overweight/obese Pregnant women | No intervention | Pregnant women who are classified as obese or overweight |
| Undernourished + Yogurt Pregnant Women | Experimental | Pregnant women who are undernourished and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. Receives: Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1 |
| Nourished + Yogurt Pregnant Women | Experimental | Pregnant women who are healthy and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. Receives: Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of gut, oral, vaginal and human milk microbiomes
Fecal, oral and vaginal samples were collected on a monthly basis for an average of four months. Human milk samples were collected twice; at birth and one week after. Microbial DNA will be extracted with the MoBio PowerSoil 96-well htp kit. Samples will be sequenced and changes determined by 16s rRNA profiling.
Measured: Monthly for an average of four months
Secondary outcomes (4)
Assessment of 48-hour Dietary Recalls
Dietary recalls will be assessed for average daily caloric, protein, carbohydrate, fat, calcium, iron, zinc, folate and vitamin intake using ESHA Food Processor SQL software.
Measured: Monthly on average for four months
Changes in body toxin levels
Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS
Measured: Before and after intervention (approximately 100 days)
Changes in blood nutrient levels
Blood nutrient levels (vitamins, macro and micr-nutrients) will be assessed by HPLC, colorimetric Biuret, chemiluminescence and HR-SF-ICP-MS
Measured: before, half-way through and after intervention (approximately 100 days)
Analysis of anthropometric measurements
Changes in weight gain, mid-upper arm circumference and hemoglobin levels will be examined and changes will be linked to intervention and non-intervention via statistical analysis.
Measured: Monthly on average for four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
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 PregnancyStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Responsible party
- Principal investigator, Dr. Gregor Reid, Western University, Canada
- Investigators
- Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS, Principal investigator, Western University, Canada; Lawson Health Research InstituteJeremy P Burton, Phd, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021799
- Sponsor's protocol ID
- 102400
- Status last verified
- Dec 2013
- First submitted
- 4 Jul 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.
PubMed 25293764
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
- ClinicalTrials.gov ID
- NCT02021799
- Acronym / sponsor ID
- 102400
- Conditions
- Pregnancy
- Keywords
- Gut microbiome, Vaginal microbiome, Oral microbiome, Human milk microbiome, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- National Institute for Medical Research, Tanzania
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Dec 2013 (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.
The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Undernourished Pregnant Women | No intervention | –Pregnant women who are classified as undernourished |
| Nourished Pregnant Women | No intervention | –Pregnant women who are classified as healthy |
| Overweight/obese Pregnant women | No intervention | –Pregnant women who are classified as obese or overweight |
| Undernourished + Yogurt Pregnant Women | Experimental | Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1Pregnant women who are undernourished and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. |
| Nourished + Yogurt Pregnant Women | Experimental | Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1Pregnant women who are healthy and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Greater than 12 weeks pregnant
- between the ages of 18 and 40 years
Key exclusion criteria (1 listed)
- Less than 12 weeks pregnant
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 |
|---|---|---|
| Moringa and Lactobacillus rhamnosus GR-1 | Dietary supplement | Nourished + Yogurt Pregnant Women, Undernourished + Yogurt Pregnant Women |
Primary outcome
Characterization of gut, oral, vaginal and human milk microbiomes
Time frame: Monthly for an average of four months
Fecal, oral and vaginal samples were collected on a monthly basis for an average of four months. Human milk samples were collected twice; at birth and one week after. Microbial DNA will be extracted with the MoBio PowerSoil 96-well htp kit. Samples will be sequenced and changes determined by 16s rRNA profiling.
4 secondary outcomes
Assessment of 48-hour Dietary Recalls
Time frame: Monthly on average for four months
Changes in body toxin levels
Time frame: Before and after intervention (approximately 100 days)
Changes in blood nutrient levels
Time frame: before, half-way through and after intervention (approximately 100 days)
Analysis of anthropometric measurements
Time frame: Monthly on average for four 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 27 Dec 2013.
- Derived from this study: PubMed 25293764Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.
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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.
Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS principal investigator
Western University, Canada; Lawson Health Research Institute
Jeremy P Burton, Phd principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa and Lactobacillus rhamnosus GR-1 in people with Pregnancy, run by Western University, Canada at 1 site in Tanzania.
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 2 inclusion and 1 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 27 Dec 2013. 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 Tanzania. 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?
Characterization of gut, oral, vaginal and human milk microbiomes (time frame: Monthly for an average of four 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 NCT02021799, 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 27 Dec 2013.