An interventional study of Symbiotic Formula with DHA and antioxidants and Standard Formula in Cystic Fibrosis, Failure to Thrive and Malnutrition, sponsored by Laboratorios Ordesa. Completed at 8 sites in 2 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Laboratorios Ordesa · Not applicable, Interventional, and Treatment
Among 87 studies in Cystic Fibrosis with a site in Spain — 7 open to participants now, 11 under way, 2 of them phase 3. Cystic Fibrosis · Spain.
Among the 87 studies in Cystic Fibrosis with a site in Spain, this one is the 39th largest by enrollment of the 79 interventional ones, is one of 4 that started in 2012, is one of 18 with no phase, and was the 23rd registered.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
This study's enrollment of 109 is above the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →7 of the 87 studies in Cystic Fibrosis with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 154 Cystic Fibrosis studies recruiting now, 95 (62%) set no upper age limit and 43 (28%) stop at 75 or younger; 84 take children under 18; 41 take healthy volunteers.
This study: 1 Year and older · all sexes · no healthy volunteers.
The full table on the hub →87 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2012.
Median enrollment 105 across the 79 interventional studies, 90 across the 8 observational. Of the 70 that completed or were terminated, 46 (66%) have results posted.
58 of 87 have an industry lead sponsor. The 10 most frequent:
Laboratorios Ordesa is the lead sponsor of 16 studies on the registry; none are open to participants now.
Laboratorios Ordesa has 1 study filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Cystic Fibrosis with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05331183Phase 3Vertex Pharmaceuticals IncorporatedStudy to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del | 2027-04-06 |
| NCT07559175Aimmune Nestlé Health Science US R&D, LLCA Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency. | 2027-06 |
| NCT06429176SpliSense Ltd.Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis | 2027-10-01 |
Among the 87 studies in Cystic Fibrosis with a site in Spain, from their registry updates:
The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Symbiotic Formula with DHA and antioxidants
Dietary Supplement: Symbiotic Formula with DHA and antioxidants
Standard isocaloric and isonitrogenous formula.
Dietary Supplement: Standard Formula
6 months intervention.
Also known as: Vitafos Junior
6 months intervention.
Changes in inflammatory response
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
Time frame: At 3rd and 6th months
Changes in nutritional status
Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
Time frame: At 3rd and 6th months
Changes in microbiota profile
Differences measured by changes in faecal microbiota composition.
Time frame: At 3rd and 6th months
Changes in Interleukin levels
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
Time frame: At 6th month
Incidence of Infections
Episodes of infections during the study period
Time frame: At 1st, 3rd and 6th months
Tolerability of the formula
Tolerability to the formula in both groups
Time frame: At 1st, 3rd and 6th months
The record gives a start of Jan 2012, a primary completion of Feb 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Laboratorios Ordesa