SustainabilityCLEARNCT03383510
Climate Friendly and Ecological Food on Microbiota
A study testing Climate friendly diet, Organic diet and Climate friendly and organic diet in people with Sustainability and Microbiota, run by Mälardalen University at 1 site in Sweden.
Trial summary
The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sustainability, Microbiota, Pesticides
- What is being tested?
- Climate friendly diet, Organic diet and Climate friendly and organic diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 31 Aug 2017to 3 May 2018
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Västerås
- Carnivores
- Healthy
Who cannot join
- Vegans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intervention Study of Sustainable Food Habits That Promotes Health and Environmental Aspects
The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits.
- Conditions
- Sustainability, Microbiota, Pesticides, Organic Food
- Being tested
- Climate friendly diet, Organic diet, Climate friendly and organic diet, Control group (Control diet)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climate friendly dietOther
Participants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals.
Organic dietOther
Participants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods.
Climate friendly and organic dietOther
The participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products.
Control group (Control diet)Other
A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the "plate model" for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy.
| Study group | Role | What they receive |
|---|---|---|
| Climate friendly group | Experimental | The climate friendly group will receive instructions to eat according to a climate friendly diet, i.e., to replace the majority of their intake of animal based products with plant based food. Receives: Other: Climate friendly diet |
| Organic group | Experimental | The organic group will receive instructions to eat an organic diet, i.e., to replace at least 50% of their normally consumed food with organic equivalents. Receives: Other: Organic diet |
| Climate friendly and organic group | Experimental | The climate friendly and organic group will receive instructions to consume a climate friendly and organic diet, i.e, to replace the majority of their intake of animal based products with plant based food AND to consume at least 50% organic food products. Receives: Other: Climate friendly and organic diet |
| Control group | Placebo comparator | The control group will receive instructions to eat according to the Nordic Nutrition Recommendations. Receives: Other: Control group (Control diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in composition of the microbiota
The investigators will assess changes over time in the presence of all gut bacteria species in the microbiome of the participants based on DNA sequencing from fecal samples. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). From frozen samples, all DNA will be extracted and full shotgun metagenomic sequencing performed using next generation sequencing technologies (Illumina and BGISEQ). A total of 120 samples (3*40 participants) will be sequenced to a depth of at least 3 giga base pairs (Gbp) each.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in concentration of pesticide residues in urine
The investigators will assess changes in concentration of four pesticide residues (Mepiquat, Chlormequat, Propamocarb and Ethylene thiourea) excreted in urine. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). The concentration of pesticide residues in urine samples will be determined in normal or reversed phase configuration on a high performance liquid chromatograph coupled to a triple quadrupole mass spectrometer (HPLC-MS/MS) system with electrospray ionization interface (ESI) run in negative or positive mode.
Measured: Baseline, after 4 weeks, after 8 weeks
Secondary outcomes (24)
Changes in intake of energy
The investigators will assess changes in intake of energy in kilojoule/day (kJ/day) when the participants shifts their diet from conventional food habits to sustainable food habits, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of energy in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: After 8 weeks
Changes in intake of protein
The investigators will assess changes in intake of protein in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of protein in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of fat
The investigators will assess changes in intake of fat in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of fat in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of carbohydrates
The investigators will assess changes in intake of carbohydrates in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of macronutrients in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of dietary fiber
The investigators will assess changes in intake of dietary fiber in kJ/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of dietary fiber in kJ by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin A
The investigators will assess changes in intake of vitamin A, measured in Retinol Equivalents per day (RE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin A in RE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin D
The investigators will assess changes in intake of vitamin D, measured in micrograms per day (μg/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin D in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin E
The investigators will assess changes in intake of vitamin E, measured in alpha-tocopherol equivalents per day (α-TE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin E in α-TE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of thiamin
The investigators will assess changes in intake of thiamin, measured in milligrams per day (mg/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of thiamin in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of riboflavin
The investigators will assess changes in intake of riboflavin, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of riboflavin in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of niacin
The investigators will assess changes in intake of niacin, measured in Niacin Equivalents per day (NE/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of niacin in NE by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin B6
The investigators will assess changes in intake of vitamin B6, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B6 in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of folate
The investigators will assess changes in intake of folate, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of folate in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin B12
The investigators will assess changes in intake of vitamin B12, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B12 in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin C
The investigators will assess changes in intake of vitamin C, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin C in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of calcium
The investigators will assess changes in intake of calcium, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of calcium in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of phosphorus
The investigators will assess changes in intake of phosphorus, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of phosphorus in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of potassium
The investigators will assess changes in intake of potassium, measured in grams per day (g/day), when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of potassium in g by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of iron
The investigators will assess changes in intake of iron, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iron in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of zinc
The investigators will assess changes in intake of zinc, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of zinc in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of iodine
The investigators will assess changes in intake of iodine, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iodine in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of selenium
The investigators will assess changes in intake of selenium, measured in μg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of selenium in μg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Changes in intake of copper
The investigators will assess changes in intake of copper, measured in mg/day, when the participants shifts their diet from conventional food habits to sustainable food habits using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of copper in mg by linkage to the National Food Composition Table using the NutriCalc program developed by the research group.
Measured: Baseline, after 4 weeks, after 8 weeks
Assessment of the participants likeability of the diets using a questionnaire
The investigators will assess the participants "likeability" of the diets by asking how likely they are to continue to adhere to them after the end of the intervention.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start31 Aug 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SustainabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarina Bälter, PhD, Principal investigator, Mälardalens Högskola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383510
- Sponsor's protocol ID
- 2017/306
- Acronym
- CLEAR
- Status last verified
- Jun 2018
- First submitted
- 29 Sep 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study of Sustainable Food Habits That Promotes Health and Environmental Aspects
- ClinicalTrials.gov ID
- NCT03383510
- Acronym / sponsor ID
- CLEAR / 2017/306
- Conditions
- Sustainability, Microbiota, Pesticides, Organic Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 26 Dec 2017 (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.
The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Climate friendly group | Experimental | Other: Climate friendly dietThe climate friendly group will receive instructions to eat according to a climate friendly diet, i.e., to replace the majority of their intake of animal based products with plant based food. |
| Organic group | Experimental | Other: Organic dietThe organic group will receive instructions to eat an organic diet, i.e., to replace at least 50% of their normally consumed food with organic equivalents. |
| Climate friendly and organic group | Experimental | Other: Climate friendly and organic dietThe climate friendly and organic group will receive instructions to consume a climate friendly and organic diet, i.e, to replace the majority of their intake of animal based products with plant based food AND to consume at least 50% organic food products. |
| Control group | Placebo comparator | Other: Control group (Control diet)The control group will receive instructions to eat according to the Nordic Nutrition Recommendations. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Living in Västerås
- Carnivores
- Healthy
Key exclusion criteria (1 listed)
- Vegans
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 |
|---|---|---|
| Climate friendly dietParticipants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals. | Other | Climate friendly group |
| Organic dietParticipants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods. | Other | Organic group |
| Climate friendly and organic dietThe participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products. | Other | Climate friendly and organic group |
| Control group (Control diet)A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the "plate model" for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy. | Other | Control group |
Primary outcome
Changes in composition of the microbiota
Time frame: Baseline, after 4 weeks, after 8 weeks
The investigators will assess changes over time in the presence of all gut bacteria species in the microbiome of the participants based on DNA sequencing from fecal samples. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). From frozen samples, all DNA will be extracted and full shotgun metagenomic sequencing performed using next generation sequencing technologies (Illumina and BGISEQ). A total of 120 samples (3*40 participants) will be sequenced to a depth of at least 3 giga base pairs (Gbp) each.
Changes in concentration of pesticide residues in urine
Time frame: Baseline, after 4 weeks, after 8 weeks
The investigators will assess changes in concentration of four pesticide residues (Mepiquat, Chlormequat, Propamocarb and Ethylene thiourea) excreted in urine. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). The concentration of pesticide residues in urine samples will be determined in normal or reversed phase configuration on a high performance liquid chromatograph coupled to a triple quadrupole mass spectrometer (HPLC-MS/MS) system with electrospray ionization interface (ESI) run in negative or positive mode.
24 secondary outcomes
Changes in intake of energy
Time frame: After 8 weeks
Changes in intake of protein
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of fat
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of carbohydrates
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of dietary fiber
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin A
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin D
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin E
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of thiamin
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of riboflavin
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of niacin
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin B6
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of folate
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin B12
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of vitamin C
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of calcium
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of phosphorus
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of potassium
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of iron
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of zinc
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of iodine
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of selenium
Time frame: Baseline, after 4 weeks, after 8 weeks
Changes in intake of copper
Time frame: Baseline, after 4 weeks, after 8 weeks
Assessment of the participants likeability of the diets using a questionnaire
Time frame: After 8 weeks
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 12 Jun 2018.
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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.
Katarina Bälter, PhD principal investigator
Mälardalens Högskola
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climate friendly diet, Organic diet and Climate friendly and organic diet in people with Sustainability and Microbiota, run by Mälardalen University at 1 site in Sweden.
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 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 12 Jun 2018. 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 Sweden. 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?
Changes in composition of the microbiota (time frame: Baseline, after 4 weeks, after 8 weeks). 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?
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 12 Jun 2018.