FPIESQUALIMNCT04643704
Quality of Life and Eating Disorders in Children With FPIES, Food Allergy or Celiac Disease
An observational study of FPIES and IgE Mediated Food Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Food allergies are associated with a decrease in quality of life. Patients with FPIES often have more food avoidance than necessary. The greater the number of avoided foods, the greater the risk of eating disorders. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- FPIES, IgE Mediated Food Allergy, Celiac Disease
- How many people
- 403 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2021to 22 Jul 2022
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients recruited from hospitalization (conventional, and day-care unit) and consultation. Healthy controls without any food avoidance recruited from consultations, hospitalisations or community. Multicentric study * Pediatric Nutrition and Gastroenterology Unit - Trousseau Hospital, APHP; * Pediatric Pneumology and Allergy Unit - Necker-Enfants Malades Hospital, APHP; * Pediatric department and Asthma and Allergy unit - Ambroise Paré Hospital, APHP.
Who may be able to join
- Any patient from 0 to 12 years of age, with FPIES or an IgE-mediated food allergy or celiac disease.
- Controls: chid from 0 to 12 years old, without any food avoidance for medical reason, and without chronical severe pathology
Who cannot join
- General exclusion criteria:
- Families and patients who do not understand French
- Cured food allergy (FPIES, IgE or non IgE-mediated food allergy)
- Allergic patient (FPIES, IgE-mediated food allergy) undergoing oral or epicutaneous tolerance induction
- Criteria for non-inclusion in the "FPIES" group:
- Patient with mixed FPIES with associated IgE-mediated symptomatology
Show all 14Show fewer
- Non IgE-mediated food allergies other than FPIES
- Criteria for non-inclusion in the "celiac disease" group:
- Patient with hypersensitivity to non-celiac gluten
- Criteria for non-inclusion in the "control" group:
- Current food avoidance, personal or in one of the household members due to allergy, or digestive disorders (abdominal pain, diarrhea for example) induced by the consumption of particular foods and requiring a strict avoidance diet
- Chronic digestive pathology (chronic inflammatory bowel disease, functional bowel disorders with a correlation of symptoms with diet, esophagitis and eosinophilic enteropathy)
- Chronic nutritional, metabolic or endocrine pathologies for which diet can have an impact: obesity, dyslipidemia, diabetes
- Severe chronic respiratory pathology (eg: cystic fibrosis, chronic respiratory failure)
Trial locations and contacts
1 site in 1 country.
France1 site
Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique
Paris
About this study
Official title: Evaluation of Quality of Life and Eating Disorders in Children With Food Protein Induced Enterocolitis Syndrom, Food Allergy or Celiac Disease
Food allergies are associated with a decrease in quality of life. Patients with FPIES often have more food avoidance than necessary. The greater the number of avoided foods, the greater the risk of eating disorders.
To date, no study about quality of life or assessment of eating difficulties has been performed in a French-speaking pediatric population with FPIES or celiac disease
Read the detailed description
1.1 Current state of knowledge
IgE-mediated food allergies are allergies whose symptoms are urticaria, angioedema, rhinoconjunctivitis, digestive signs, bronchospasm, or even anaphylaxis within 2 hours after ingestion of food. The prevalence of these food allergies in children ranges from 1.6% to 5.6%. Patients with food allergy should follow a strict avoidance diet of the culprit food, until tolerance get acquired in a few months or years later. The avoidance diet is set up by the parents, and must be applied in all places where the child lives (family, nursery and school). Careful reading of the labels and displays in collective restorations are essential in order to limit accidental ingestion. For the most ubiquitous and / or risky foods, parents often have to provide packed lunches. An IgE-mediated emergency kit is required, containing an antihistamine, and sometimes a self-injectable epinephrine pen and bronchodilators. The protocol in the event of an allergic reaction must be known by all caregivers for the child, in order to react immediately if necessary.
Food protein-induced enterocolitis syndrome or FPIES is one of the non IgE-mediated forms of food allergy. Incidence is estimated around 0.015-0.7% in infants and children. FPIES symptoms are delayed: vomiting within 1 to 4 hours after ingestion of the offending food, associated with other symptoms such as lethargy with pallor, diarrhea secondarily. Unlike other non IgE-mediated allergies, FPIES is a potentially severe allergy, with hypovolemic shock seen in 15-33% of cases with dehydration. The most frequently offending foods are ubiquitous, such as milk, fish, eggs, rice and oats. The management of patients with FPIES consists of the avoidance of the offending food(s) until that tolerance is acquired spontaneously in a few months or years. A specific first aid kit is also prescribed, in order to limit dehydration in the event of vomiting after an accident of ingestion, with at least oral rehydration solution.
Celiac disease is a gluten-induced autoimmune enteropathy responsible for digestive malabsorption. It affects 1.4% of the population in the world. The symptoms are very varied, such as chronic diarrhea or chronic constipation resistant to laxative treatment, abdominal distension, chronic fatigue, weight loss and growth retardation, nutritional deficiencies. The treatment consists of a lifelong elimination of gluten only (strict for wheat, rye, barley, and controlled for oats). To date, celiac disease is not curable, but the elimination diet allows clinical, biological and histological normalization in the digestive mucosa. Unlike FPIES or IgE-mediated allergies, the patient and their family do not have to fear a severe reaction in case of accidental exposure, and no first aid kit is required.
1.2 Description of the population to be studied and justification of their choice
FPIES and IgE-mediated food allergies primarily affect young children. A limiting factor in terms of age for this study is the fact that the Food Allergy Quality of Life Questionnaire (FAQLQ) has not been translated into French for adolescents over 12 years old.
The population studied is therefore children under 12 years of age, with a diagnosis of FPIES, IgE-mediated allergy or celiac disease. A control group is also planned to be included.
1.3 Description of the elements covered by the study
. Quality of Life
Food allergies negatively impact the quality of life of patients and their families due to prolonged and restrictive avoidance diet.
The quality of life of children with celiac disease does not differ from that of healthy children.
In our experience, parents of patients with FPIES often report fear of another impressive allergic reaction, with profuse vomiting, and a child described as lethargic and pale during the reaction.
Parents sometimes prefer to delay entering the community in the face of fear of accidental exposure to the culprit allergen, or the fear of a reaction with the introduction of new food, especially if the child is already allergic to several groups of food.
The quality of life of families is more impaired in cases of FPIES than in cases of IgE-mediated food allergy.
During childhood, there are 2 ways to assess the quality of life: a) by measuring the quality of life of the child himself, or b) by measuring the quality of life of the child according to the perception of parents.
The generic PedsQLTM quality of life questionnaire was validated in English and in French to assess children's quality of life, using a form to be completed by parents from birth and / or by the child after the age of 5.
Food allergy-specific quality of life questionnaires: FAQL-PB (Food Allergy Quality of Life-Parental Burden) and FAQLQ-PF (Food Allergy Quality of Life Questionnaire - Parent Form) have been validated for IgE-mediated food allergies and in FPIES in parents of children aged 0 to 12 in an English version. There is also a French version of FAQLQ-PF and FAQLQ-CF (Food Allergy Quality of Life Questionnaire - Child Form).
To date, no quality of life study has been performed in a French-speaking pediatric population with FPIES or celiac disease.
Eating disorders
Food neophobia is physiological between the ages of 2 and 6, but becomes pathologic if it persists beyond 6 years or if it is exacerbated between 2 and 6 years. It is defined by a refusal to eat foods which are new or not known by the child.
Although the majority of patients with FPIES are allergic to only one food, children's diets are often over-restricted to several food groups.
Eating disorders affect 22 to 50% of children with FPIES. These are mainly food refusals, swallowing or chewing difficulties, and sensory disturbance. The risk of food refusal is increased in the event of multiple-food FPIES. In a cohort of 32 patients, only half of these patients received a specialist opinion for the management of eating disorders, probably due to default screening for these disorders.
The French Child Food Rejection Scale (CFRS) score allows screening for food neophobia and pickiness in children aged 2 to 7.
For older children (over 7 years old) and adults, there is the Food Neophobia Scale (FNS), adapted in French (AFNS: Adapted Food Neophobia Scale).
To date, no study has evaluated eating disorders in a French-speaking pediatric population with FPIES or celiac disease.
1.4 Rationale for the duration of the study The research will last at least 2 years. The goal is to include at least 100 patients with FPIES, 100 patients with IgE-mediated food allergy other than FPIES, 100 patients with celiac disease and 100 control patients.
- Conditions
- FPIES, IgE Mediated Food Allergy, Celiac Disease
- Keywords
- Quality of life, Food avoidance, restriction, Food allergy, Feeding disorder, Psychology
- Medical subject headings
- Food Hypersensitivity, Celiac Disease, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FPIES | 100 patients | |
| IgE mediated food allergy | 100 patients | |
| Celiac disease | 100 patients | |
| Control group | 100 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL) in children with FPIES
FAQLQ (Food Allergy Quality of Life Questionnaire)-PF (Parent form) for parents of children from 0 to 12 years old with FPIES FAQLQ-CF (Child Form) for children between 8 to 12 years old with FPIES PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with FPIES
Measured: 12 months
Secondary outcomes (7)
Food neophobia in children with FPIES
CFRS (Child Food Rejection Scale) for children with FPIES from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children with FPIES from 8 to 12 years old
Measured: 24 months
QoL in children with food allergy
FAQLQ-PF for parents of children from 0 to 12 years old with IgE-mediated food allergy FAQLQ-CF for children between 8 to 12 years old with IgE-mediated food allergy PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy
Measured: 24 months
QoL in children with celiac disease
: generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy PedsQLTM child form: generic questionnaire of QoL for children from 5 to 12 years old
Measured: 24 months
QoL in children without any food avoidance
PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy PedsQLTM child form: generic questionnaire of QoL for children from 5 to 12 years old
Measured: 24 months
Food neophobia in children with food allergy
CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old
Measured: 24 months
Food neophobia in children with celiac disease
CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old
Measured: 24 months
Food neophobia in children without any food avoidance
CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start5 Jan 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FPIESStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anaïs Lemoine, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643704
- Sponsor's protocol ID
- APHP201063
- Other IDs
- IDRCB 2020-A02017-32
- Acronym
- QUALIM
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life and Eating Disorders in Children With Food Protein Induced Enterocolitis Syndrom, Food Allergy or Celiac Disease
- ClinicalTrials.gov ID
- NCT04643704
- Acronym / sponsor ID
- QUALIM / APHP201063
- Conditions
- FPIES, IgE Mediated Food Allergy, Celiac Disease
- Keywords
- Quality of life, Food avoidance, restriction, Food allergy, Feeding disorder, Psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 25 Nov 2020 (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.
Food allergies are associated with a decrease in quality of life. Patients with FPIES often have more food avoidance than necessary. The greater the number of avoided foods, the greater the risk of eating disorders.
To date, no study about quality of life or assessment of eating difficulties has been performed in a French-speaking pediatric population with FPIES or celiac disease
Detailed description
1.1 Current state of knowledge
IgE-mediated food allergies are allergies whose symptoms are urticaria, angioedema, rhinoconjunctivitis, digestive signs, bronchospasm, or even anaphylaxis within 2 hours after ingestion of food. The prevalence of these food allergies in children ranges from 1.6% to 5.6%. Patients with food allergy should follow a strict avoidance diet of the culprit food, until tolerance get acquired in a few months or years later. The avoidance diet is set up by the parents, and must be applied in all places where the child lives (family, nursery and school). Careful reading of the labels and displays in collective restorations are essential in order to limit accidental ingestion. For the most ubiquitous and / or risky foods, parents often have to provide packed lunches. An IgE-mediated emergency kit is required, containing an antihistamine, and sometimes a self-injectable epinephrine pen and bronchodilators. The protocol in the event of an allergic reaction must be known by all caregivers for the child, in order to react immediately if necessary.
Food protein-induced enterocolitis syndrome or FPIES is one of the non IgE-mediated forms of food allergy. Incidence is estimated around 0.015-0.7% in infants and children. FPIES symptoms are delayed: vomiting within 1 to 4 hours after ingestion of the offending food, associated with other symptoms such as lethargy with pallor, diarrhea secondarily. Unlike other non IgE-mediated allergies, FPIES is a potentially severe allergy, with hypovolemic shock seen in 15-33% of cases with dehydration. The most frequently offending foods are ubiquitous, such as milk, fish, eggs, rice and oats. The management of patients with FPIES consists of the avoidance of the offending food(s) until that tolerance is acquired spontaneously in a few months or years. A specific first aid kit is also prescribed, in order to limit dehydration in the event of vomiting after an accident of ingestion, with at least oral rehydration solution.
Celiac disease is a gluten-induced autoimmune enteropathy responsible for digestive malabsorption. It affects 1.4% of the population in the world. The symptoms are very varied, such as chronic diarrhea or chronic constipation resistant to laxative treatment, abdominal distension, chronic fatigue, weight loss and growth retardation, nutritional deficiencies. The treatment consists of a lifelong elimination of gluten only (strict for wheat, rye, barley, and controlled for oats). To date, celiac disease is not curable, but the elimination diet allows clinical, biological and histological normalization in the digestive mucosa. Unlike FPIES or IgE-mediated allergies, the patient and their family do not have to fear a severe reaction in case of accidental exposure, and no first aid kit is required.
1.2 Description of the population to be studied and justification of their choice
FPIES and IgE-mediated food allergies primarily affect young children. A limiting factor in terms of age for this study is the fact that the Food Allergy Quality of Life Questionnaire (FAQLQ) has not been translated into French for adolescents over 12 years old.
The population studied is therefore children under 12 years of age, with a diagnosis of FPIES, IgE-mediated allergy or celiac disease. A control group is also planned to be included.
1.3 Description of the elements covered by the study
. Quality of Life
Food allergies negatively impact the quality of life of patients and their families due to prolonged and restrictive avoidance diet.
The quality of life of children with celiac disease does not differ from that of healthy children.
In our experience, parents of patients with FPIES often report fear of another impressive allergic reaction, with profuse vomiting, and a child described as lethargic and pale during the reaction.
Parents sometimes prefer to delay entering the community in the face of fear of accidental exposure to the culprit allergen, or the fear of a reaction with the introduction of new food, especially if the child is already allergic to several groups of food.
The quality of life of families is more impaired in cases of FPIES than in cases of IgE-mediated food allergy.
During childhood, there are 2 ways to assess the quality of life: a) by measuring the quality of life of the child himself, or b) by measuring the quality of life of the child according to the perception of parents.
The generic PedsQLTM quality of life questionnaire was validated in English and in French to assess children's quality of life, using a form to be completed by parents from birth and / or by the child after the age of 5.
Food allergy-specific quality of life questionnaires: FAQL-PB (Food Allergy Quality of Life-Parental Burden) and FAQLQ-PF (Food Allergy Quality of Life Questionnaire - Parent Form) have been validated for IgE-mediated food allergies and in FPIES in parents of children aged 0 to 12 in an English version. There is also a French version of FAQLQ-PF and FAQLQ-CF (Food Allergy Quality of Life Questionnaire - Child Form).
To date, no quality of life study has been performed in a French-speaking pediatric population with FPIES or celiac disease.
Eating disorders
Food neophobia is physiological between the ages of 2 and 6, but becomes pathologic if it persists beyond 6 years or if it is exacerbated between 2 and 6 years. It is defined by a refusal to eat foods which are new or not known by the child.
Although the majority of patients with FPIES are allergic to only one food, children's diets are often over-restricted to several food groups.
Eating disorders affect 22 to 50% of children with FPIES. These are mainly food refusals, swallowing or chewing difficulties, and sensory disturbance. The risk of food refusal is increased in the event of multiple-food FPIES. In a cohort of 32 patients, only half of these patients received a specialist opinion for the management of eating disorders, probably due to default screening for these disorders.
The French Child Food Rejection Scale (CFRS) score allows screening for food neophobia and pickiness in children aged 2 to 7.
For older children (over 7 years old) and adults, there is the Food Neophobia Scale (FNS), adapted in French (AFNS: Adapted Food Neophobia Scale).
To date, no study has evaluated eating disorders in a French-speaking pediatric population with FPIES or celiac disease.
1.4 Rationale for the duration of the study The research will last at least 2 years. The goal is to include at least 100 patients with FPIES, 100 patients with IgE-mediated food allergy other than FPIES, 100 patients with celiac disease and 100 control patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FPIES | – | –100 patients |
| IgE mediated food allergy | – | –100 patients |
| Celiac disease | – | –100 patients |
| Control group | – | –100 patients |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients recruited from hospitalization (conventional, and day-care unit) and consultation. Healthy controls without any food avoidance recruited from consultations, hospitalisations or community. Multicentric study * Pediatric Nutrition and Gastroenterology Unit - Trousseau Hospital, APHP; * Pediatric Pneumology and Allergy Unit - Necker-Enfants Malades Hospital, APHP; * Pediatric department and Asthma and Allergy unit - Ambroise Paré Hospital, APHP.
Key inclusion criteria (2 listed)
- Any patient from 0 to 12 years of age, with FPIES or an IgE-mediated food allergy or celiac disease.
- Controls: chid from 0 to 12 years old, without any food avoidance for medical reason, and without chronical severe pathology
Key exclusion criteria (14 listed)
- Families and patients who do not understand French
- Cured food allergy (FPIES, IgE or non IgE-mediated food allergy)
- Allergic patient (FPIES, IgE-mediated food allergy) undergoing oral or epicutaneous tolerance induction
- Patient with mixed FPIES with associated IgE-mediated symptomatology
- Non IgE-mediated food allergies other than FPIES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life (QoL) in children with FPIES
Time frame: 12 months
FAQLQ (Food Allergy Quality of Life Questionnaire)-PF (Parent form) for parents of children from 0 to 12 years old with FPIES FAQLQ-CF (Child Form) for children between 8 to 12 years old with FPIES PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with FPIES
7 secondary outcomes
Food neophobia in children with FPIES
Time frame: 24 months
QoL in children with food allergy
Time frame: 24 months
QoL in children with celiac disease
Time frame: 24 months
QoL in children without any food avoidance
Time frame: 24 months
Food neophobia in children with food allergy
Time frame: 24 months
Food neophobia in children with celiac disease
Time frame: 24 months
Food neophobia in children without any food avoidance
Time frame: 24 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 28 Sep 2022.
- Individual participant dataSharing planned: Yes
Related trials for FPIES
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Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
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Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome
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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.
Anaïs Lemoine principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FPIES and IgE Mediated Food Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 14 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 28 Sep 2022. 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 France. 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?
Quality of life (QoL) in children with FPIES (time frame: 12 months). 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 28 Sep 2022.