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Cystic Fibrosis - ClinicalTrials.gov

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Last Updated: 23 June 2022

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Intimacy of Women With Cystic Fibrosis

The intimate life of patients with cystic fibrosis has not been the subject of rigorous study; it is also ignored in favour of respiratory, digestive, or endocrinological disorders endangering these patients. These disorders are caused by the disease's effects on the wellbeing of the mucous epithelial tissues that are also present in the genital region. These difficulties are more closely linked to fertility: PMA encourages them to get around them, while still making it possible to be a parent with the lingering pain of a healthy sex life: a deaf "addition" adding to many care challenges. It is therefore essential to improve sexual stability and quality of sexual life that it is also important to shed light on this issue of cystic fibrosis in women.

Source link: https://clinicaltrials.gov/ct2/show/NCT04225962


Genetic Modifiers of Cystic Fibrosis Related Diabetes

Both the cystic fibrosis transmembrane conductance regulator gene and the entire genome are tested for variation. We identify genetic variations associated with CFRD using large numbers of people with CF, as well as finding who does and does not have CFRD. In addition to the study, people participating in this research also have the opportunity to enroll in related studies of other health risk factors in CF, such as over- and underweight.

Source link: https://clinicaltrials.gov/ct2/show/NCT01113216


Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit

Gastric muscle rhythms in CF patients were determined by pre and postprandial electrogastrography, resulting in postprandial bradygastria. Overall, CF patients were shown to have a delayed intestine transit time with the magnetic pill reaching the cecum in just 2 of 10 CF patients in a 7-hour period compared to 14 of 16 control patients. In 90% of Cystic Fibrosis mice, use of Miralax or polyethylene glycol laxative reduced bacterial overgrowth in 90% of Cystic Fibrosis mice, according to Mouse studies. In a small group of CF patients, daily PEG use in the daily PEG dose reduced positive breath tests. Although there have been several studies demonstrating the clinical enhancement of SIBO and DIOS with PEG and/or other laxative agents, no one has reported whether or not these drugs improve intestinal transit time. This research study is designed to determine total intraluminal transit time in CF patients and the effects of PEG on transit time and patient symptoms. Initial recruiting visit: Informed consent to participate in the study will be obtained. The patient will have to undergo a 2 week washout period, during which all non-essential medications that affect gut motility are temporarily suspended. If the SmartPill is not excreted after day 7, the patient will have an outpatient abdominal X-ray to determine if the SmartPill unit is retained in the intestines. The patient will begin polyethylene glycol 17 g therapy for a total of two weeks after 7 days. Second visit: The patient will repeat the Rome IV Diagnostic Questionnaire for Adult FGIDs and ingest the second SmartPill to measure change in gut motility following initiation of therapy. The SmartPill is considered a research procedure. Up to seven days after the capsule was ingested, the patient will return the receiver. If the SmartPill is not excreted after day 7, the patient will perform an outpatient abdominal XRay to determine if the SmartPill unit is retained in the intestines. **If there is a suspicion that the SmartPill is not retained in the intestine, the patient may be asked to take a Patency agile capsule. The patient will return the recording equipment for review and completion of their therapy log detailing how the drug was administered on his fourth visit: The patient will return the recorder equipment for analysis, will complete a post study questionnaire and undergo a review of how the medications were administered.

Source link: https://clinicaltrials.gov/ct2/show/NCT04210427


COVID-19 Antibody Responses In Cystic Fibrosis

Every time the participant goes to the hospital for blood draws, additional blood samples will be collected opportunistically. The investigators will also obtain clinical data from the patient's health records and then enter this data into the case report format alongside the blood samples. According to local clinical practice, clinical data will be collected in conjunction with routine healthcare visits. Background demographics, CF medical history, drugs, exacerbation data, sputum microbiology, and lung function parameters will be included in the collection, as well as cardiac and lung function parameters. This research period is justified because it provides sufficient time to track changes in antibody prevalence over the course of the COVID-19 pandemic as well as sufficient time to determine long-term clinical outcomes for pwCF who are SARS-CoV-2 seropositive. In addition, the investigators expect that the 2-year research follow-up period will allow sufficient time to determine the effects of vaccination on antibody levels given that a number of vaccines are now commercially available. The investigators will determine how antibody responses in pwCF vary with time as a result of natural COVID-19 infection and immunization will be compared. Optional Study sample collection: For participants who consent, a second blood sample will also be drawn into EDTA tubes. CONSENT to this optional study sample will enable this sample and any remaining serum to be stored for future analysis and allow further research into COVID-19 and CF.

Source link: https://clinicaltrials.gov/ct2/show/NCT05074680


Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

Patients with high rates of patient dissatisfaction with new GI treatments, fullness with meals, and abdominal distension were among the key findings from our largest study of patient-reported GI symptom outcomes in CF, including 402 adults and children with CF.

Source link: https://clinicaltrials.gov/ct2/show/NCT05408910


Symptom Based Performance of Airway Clearance Therapy After Starting Highly Effective CFTR Modulator Therapy for Cystic Fibrosis

For the 12-week trial period, participants in each of the study visits will be required to perform home spirometry once a week. After either twice a day airway clearance procedure or for the symptom-based group to perform at roughly the same time of day for each test, the investigators will ask for participants to perform home spirometry. During the run-in period and research period, participants will also be required to keep a daily cystic fibrosis diary, in which participants will note if and how often participants use any airway clearance products or devices during the day. A decrease in ppFEV1% and/or ppFVC% in home spirometry by more than 10% will suggest the need for more than 10% in lab PFT testing to determine whether participants have caused an adverse occurrence that led to daily airway clearance examinations or continuing symptoms-based airway clearance. Participants will receive prompt medical assistance if they experience an exacerbation from a known cause other than their primary CF lung disease sufferers, and although the case will be deemed an adverse event, participants will continue with their current treatment regimen. The investigators will not require any discontinuation of additional inhaler/nebulized drugs that are asthma-specific, but no bronchodilators will be tested specifically for the research.

Source link: https://clinicaltrials.gov/ct2/show/NCT05392855

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions