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NCT Number: NCT02105714

Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks.

While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment.

The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (Côte d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a "case-control" design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries

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Key information

Conditions

Soil-transmitted Helminthiasis Abdominal Pain Aeromonas Spp. Infections Amebiasis Amoebiasis Bacterial Infections Bacterial Infections and Mycoses Campylobacter Infections Campylobacteriosis Cryptosporidium Spp. Infections Diarrhea Dientamoebiasis Digestive System Diseases Dysentery Dysentery, Bacillary Enterobacteriaceae Infections Gastroenteritis Gastrointestinal Diseases Giardiasis Gram-Negative Bacterial Infections Helminthiasis Infections Intestinal Diseases Intestinal Diseases, Parasitic Intestinal Salmonellosis Nematode Infections Neurologic Manifestations Pain Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Rhabditida Infections Schistosomiasis Secernentea Infections Shigellosis Signs and Symptoms Signs and Symptoms, Digestive Strongyloidiasis Trematode Infections Vector Borne Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Méthodiste de Dabou, Dabou, Côte d’Ivoire

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence).
  • Individuals with written informed consent provided.

Exclusion criteria

  • Individuals in need of immediate intensive or surgical care.
  • Individuals who are unable or unwilling to give written informed consent.
  • Individuals who do not meet the inclusion criteria for being a case or control (e.g. people with acute diarrhoea).
  • Individuals with clinical jaundice (assessed by direct observation of the conjunctivae).
  • Individuals who are unable, in the study physician's opinion, to comply with the study requirements.
  • Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials.

Treatment and study plan

Stool culturing for pathogenic bacteria

Procedure

Kato-Katz technique

Procedure

Baermann technique

Procedure

Mini-FLOTAC

Device

Crypto/Giardia Duo Strip

Device

Formalin-ether concentration technique

Procedure

CCA RDT

Device

Koga agar plate culture

Procedure

Kinyoun staining

Procedure

Multiplex PCR

Device

Metagenomics analysis

Procedure

Primary outcomes

  1. Prevalence of neglected tropical diseases (NTDs) causing persistent digestive disorders (≥2 weeks)

    Time frame: 18 months

    The frequency, distribution, and if possible, intensity of target NTDs

Secondary outcomes

  1. Sensitivity, specificity, crude and adjusted likelihood ratios (LR) and predictive values (post-test probabilities) of clinical features and laboratory tests for the diagnosis of target NTDs

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • B.P. Koirala Institute of Health Sciences
  • Gadjah Mada University
  • Institut de Recherche en Santé Publique, France
  • Institute of Tropical Medicine, Belgium
  • Université Félix Houphouët-Boigny

Registry information

Official study title

Diagnosis of Neglected Tropical Diseases (NTDs) in Patients Presenting With Persistent Digestive Disorders (≥2 Weeks) in Côte d'Ivoire, Indonesia, Mali and Nepal

Acronym: NIDIAGDigest

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2014
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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